Biomonitoring systems and methods of loading and releasing the same

ABSTRACT

A system and method for monitoring body chemistry of a user, the system comprising: a housing supporting: a microsensor comprising a first and second working electrode, a reference electrode, and a counter electrode, and configured to access interstitial fluid of the user, and an electronics subsystem comprising a signal conditioning module that receives a signal stream, from the microsensor, wherein the electronics subsystem is configured to detect an impedance signal derived from two of the first working electrode, the second working electrode, the reference electrode, and the counter electrode; and a processing subsystem comprising: a first module configured to generate an analysis indicative of an analyte parameter of the user and derived from the signal stream and the impedance signal, and a second module configured to transmit information derived from the analysis to the user, thereby facilitating monitoring of body chemistry of the user.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.17/409,611, filed Aug. 23, 2021, which is a continuation of U.S.application Ser. No. 17/182,097, filed Feb. 22, 2021 (U.S. Pat. No.11,172,851), which is a continuation of U.S. application Ser. No.16/791,518, filed Feb. 14, 2020, which is a continuation of U.S.application Ser. No. 15/601,204, filed May 22, 2017 (U.S. Pat. No.10,595,754), which is a continuation-in-part of U.S. application Ser.No. 15/412,229, filed Jan. 23, 2017, which is a continuation of U.S.application Ser. No. 14/657,973, filed Mar. 13, 2015, which claimspriority to U.S. Provisional Application No. 62/025,174, filed Jul. 16,2014, U.S. Provisional Application No. 62/012,874, filed Jun. 16, 2014,and U.S. Provisional Application No. 61/952,594, filed Mar. 13, 2014,all of which are incorporated by reference herein in their entireties.

TECHNICAL FIELD

This invention relates generally to the biometric device field, and morespecifically to a new and useful system for monitoring body chemistry inthe biometric device field.

BACKGROUND

Biomonitoring devices are commonly used, particularly byhealth-conscious individuals and individuals diagnosed with ailments, tomonitor body chemistry. Such biomonitoring devices perform the tasks ofdetermining an analyte level in a user's body, and providing informationregarding the analyte level to a user; however, these currentbiomonitoring devices typically convey information to users that islimited in detail, intermittent, and prompted by the command of theuser. Such biomonitoring devices, including blood glucose meters, arealso inappropriate for many applications outside of intermittent use,and place significant burdens on users (e.g., in requiring fingersticks, in requiring lancing, etc.) due to design and manufactureconsiderations. Additionally, current devices are configured to analyzeone or a limited number of analytes contributing to overall bodychemistry, due to limitations of sensors used in current biomonitoringdevices.

There is thus a need in the biometric device field to create a new anduseful system for monitoring body chemistry. This invention providessuch a new and useful system.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 depicts elements of an embodiment of a system for monitoring bodychemistry;

FIGS. 2A and 2B depict embodiments of a microsensor patch, atransmitting unit, a housing, and an array of filaments in an embodimentof a system for monitoring body chemistry;

FIG. 2C depict a variation of electrodes in an embodiment of a systemfor monitoring body chemistry;

FIGS. 3A-3H depict examples of filament variations in an embodiment of asystem for monitoring body chemistry;

FIG. 4 depicts an embodiment of an electronics subsystem in anembodiment of a system for monitoring body chemistry;

FIGS. 5A-5C depict examples of a portion of an electronics subsystem inan embodiment of a system for monitoring body chemistry;

FIGS. 6A-6B depict examples of power management modules in an embodimentof a system for monitoring body chemistry;

FIG. 7 depicts a variation of an impedance detection module in anembodiment of a system for monitoring body chemistry;

FIG. 8 depicts an example of an applied voltage waveform in anembodiment of a system for monitoring body chemistry;

FIG. 9 depicts a variation of a housing in an embodiment of a system formonitoring body chemistry;

FIGS. 10A-10B depict specific examples of a housing in an embodiment ofa system for monitoring body chemistry;

FIG. 10C depicts a specific portion of a housing in an embodiment of asystem for monitoring body chemistry;

FIGS. 10D and 10E depict specific portions of a housing in an embodimentof a system for monitoring body chemistry;

FIGS. 11A-11B depict examples of user interfaces implemented using asoftware module in an embodiment of a system for monitoring bodychemistry;

FIG. 12A depicts a notification module of an embodiment of a system formonitoring body chemistry;

FIGS. 12B-12C depict specific examples of notifications in an embodimentof a system for monitoring body chemistry;

FIG. 13 depicts communication between a processing subsystem and astorage module in an embodiment of a system for monitoring bodychemistry;

FIGS. 14A-14C depict examples of an arch application method and anend-to-end application method, respectively, in an embodiment of asystem for monitoring body chemistry;

FIG. 15 depicts an embodiment of an applicator system in an embodimentof a system for monitoring body chemistry;

FIGS. 16A and 16B depict a first specific example of an applicatorsystem in an embodiment of a system for monitoring body chemistry;

FIGS. 17A and 17B depict a second specific example of an applicatorsystem in an embodiment of a system for monitoring body chemistry;

FIGS. 18A-18B depict variations of a applicator system in an embodimentof a system for monitoring body chemistry;

FIGS. 19A-19D depict a first specific example of a applicator system inan embodiment of a system for monitoring body chemistry;

FIG. 20 depicts a second specific example of a applicator system in anembodiment of a system for monitoring body chemistry;

FIGS. 21A-21B depict a specific example of a base station in anembodiment of a system for monitoring body chemistry;

FIG. 22 depicts operation modes of components of an embodiment of asystem for monitoring body chemistry;

FIG. 23 depicts an embodiment of a method for monitoring body chemistry;

FIG. 24 depicts a portion of a variation of a system for monitoring bodychemistry;

FIG. 25 depicts an example of a portion of an electronics subsystem in asystem for monitoring body chemistry;

FIGS. 26A and 26B depict an example of a portion of a system formonitoring body chemistry;

FIG. 27 depicts an example of a liner in an embodiment of a system formonitoring body chemistry; and

FIGS. 28A-28B depict examples of liners in an embodiment of a system formonitoring body chemistry.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following description of the preferred embodiments of the inventionis not intended to limit the invention to these preferred embodiments,but rather to enable any person skilled in the art to make and use thisinvention.

1. System

As shown in FIG. 1, an embodiment of the system 100 for monitoring bodychemistry of a user comprises a housing 190 that supports a microsensor116 and an electronics subsystem 120 in communication with themicrosensor 116; and a processing subsystem 160 configured to generatean analysis indicative of an analyte parameter of the user, wherein theanalysis is derived from a signal stream of the microsensor and animpedance signal from the electronics subsystem. In more detail, thehousing 190, microsensor 116, and the electronics subsystem 120 can beconfigured as a microsensor patch 110 configured to sense analyte levelsin a user's body, wherein the electronics subsystem includes a signalconditioning module 122, a power management module 124, a storage module127, and a transmitting unit 130 in communication with the processingsubsystem 160 and/or an electronic device (e.g., mobile computing device150) associated with the user.

In some variations, the system 100 can further include a applicatorsystem 180 configured to facilitate application of the microsensor patch110 onto the body of a user in a reliable manner. The system 100functions to provide continuous monitoring of a user's body chemistrythrough reception and processing of signals associated with one or moreanalytes present in the body of the user, and to provide an analysis ofthe user's body chemistry to the user and/or an entity (e.g., healthcare professional, caretaker, relative, friend, acquaintance, etc.)associated with the user. Alternatively, the system 100 can function todetect a user's body chemistry upon the user's request or sporadically,and/or can provide an analysis of the user's body chemistry only to theuser.

The system 100 is configured to be worn by the patient outside of aclinical (e.g., hospital) or research (e.g., laboratory) setting, suchthat the patient can be in a non-contrived environment as he or she isinterfacing with the microsensor patch 110 for monitoring of bodychemistry. Furthermore, elements of the system 100 can be reusable ordisposable (e.g., based upon modularity of the system 100), or theentire system 100 can be configured to be disposable. In one specificexample, the system 100 adheres to the patient (thus not compelling thepatient to hold any part of the system 100 by hand), has a low profilethat conforms to the patient, and is configured to receive and transmitsignals indicative of body chemistry parameters of the user, fordownstream analysis and information transfer to the user. Alternatively,the system 100 can be substantially non-portable, non-wearable, and/orintended for use in a clinical or research setting.

As indicated above and further below, elements of the system can beimplemented on one or more computer networks, computer systems, orapplications servers, etc. The computer system(s) can comprise one ormore of: a cloud-based computer, a mainframe computer system, agrid-computer system, or any other suitable computer system, and thecomputer system can support collection of data from a wearable deviceand/or a base station, processing of these data, and transmission ofalerts, notifications, and/or user interface updates to one or moreelectronic computing devices (e.g., mobile computing device, wrist-bornemobile computing device, head-mounted mobile computing device, etc.)linked to or affiliated with an account of the user. For example, thecomputer system can receive signals indicative of one or more analyteparameters of the user and distribute alerts and notifications over adistributed network, such as over a cellular network or over an Internetconnection. In this example, the computer system can upload alerts andnotifications to a native body chemistry monitoring applicationincluding the user interface and executing on a mobile computing deviceassociated with the user.

Additionally or alternatively, an electronic computing device (e.g., alaptop computer, a desktop computer, a tablet, a smartphone, a smartwatch, a smart eyewear accessory, a personal data assistant, etc.)associated with the system (e.g., with the account of the user) canmaintain the account of the user, create and maintain a user-specificmodel within the account, and execute a native body chemistry monitoringapplication (including the user interface) with functions including oneor more of: generating alerts or notifications, receiving alerts ornotifications, displaying alerts or notifications, updating predictionsof changes in state of the user, and any other suitable function thatenhances body chemistry monitoring of the user. The system 100 ispreferably configured to implement at least a portion of the method 200described in Section 2 below; however, the system 100 can additionallyor alternatively b e configured to implement any other suitable method.

1.1 System—Microsensor Patch

As shown in FIG. 1, the microsensor patch 110 comprises a microsensor116 and an electronics subsystem 120 in communication with themicrosensor 116, wherein the microsensor 116 and the electronicssubsystem 120 are supported by a housing 190. The microsensor patch 110can be configured to detect and sense only a single analyte; however,the microsensor patch 110 can alternatively be configured to detect andsense multiple analytes in order to provide an analysis based onmultiple analytes. Preferably, the microsensor patch 110 is configuredto be disposable; however, the microsensor patch 110 can alternativelybe configured to be reusable for any suitable duration or number ofuses. In one variation, the microsensor patch 110 is configured to be asemi-permanent component (e.g., wearable for a week before replacement,wearable for a month before replacement, etc.) configured to sense theuser's body chemistry with minimal signal degradation for at a least aweek post-coupling of the microsensor patch 110 to the body of the user.However, in another variation, the microsensor patch 110 can beconfigured to be a permanent component configured to permanently coupleto a user. Modularity of the microsensor patch 110 is described infurther detail below.

1.1.1 System—Microsensor

The microsensor 116 of the microsensor patch 110 preferably comprises anarray of filaments 117, as shown in FIGS. 1 and 2A, and functions topenetrate skin of the user in order to sense one or more analytescharacterizing the user's body chemistry. Preferably, the array offilaments 117 is configured to penetrate the user's stratum corneum(i.e., an outer skin layer) in order to sense analytes withininterstitial (extracellular) fluid, which is throughout the body;however, the array of filaments 117 can be configured to penetrate theuser's skin to any other suitable depth. For instance, the microsensor116 can alternatively be configured to penetrate deeper layers, orvarious depth layers of a user's skin in order to sense analytes withinany appropriate bodily fluid of the user. The microsensor 116 can beconfigured to sense analytes/ions characterizing a user's body chemistryusing a potentiometric measurement (e.g., for small analytes includingpotassium, sodium calcium, etc.), using an amperometric measurement(e.g., for large analytes including glucose, lactic acid, creatinine,etc.), using a conductometric measurement, and/or using any othersuitable measurement.

Preferably, sensed analytes result in a signal (e.g., voltage, current,resistance, capacitance, impedance, gravimetric, etc.) detectable by theelectronics subsystem 120 in communication with the microsensor 116;however, analyte sensing can comprise any other appropriate mechanismusing the microsensor 116. As mentioned earlier, the microsensor 116 isalso preferably integrated with the electronics subsystem 120. In afirst variation, the microsensor 116 is coupled to the semiconductorarchitecture of the electronics subsystem 120 (e.g., the microsensor 116is coupled to an integrated circuit comprising the electronics subsystem120), in a second variation, the microsensor 116 is more closelyintegrated into the semiconductor architecture of the electronicssubsystem 120 (e.g., there is closer integration between the microsensor116 and an integrated circuit including the electronics subsystem 120),and in a third variation, the microsensor 116 and the electronicssubsystem 120 are constructed in a system-on-a-chip fashion (e.g., allcomponents are integrated into a single chip). As such, in somevariations, filaments the array of filaments 117 of the microsensor 116can be directly or indirectly integrated with electronics components,such that preprocessing of a signal from the microsensor 116 can beperformed using the electronics components (e.g., of the array offilaments 117, of the electronics subsystem 120) prior to or aftertransmitting signals to the electronics subsystem 120 (e.g., to ananalog front end, to an analog to digital converter). The electronicscomponents can be coupled to a filament substrate, or otherwiseintegrated with the filaments in any suitable fashion (e.g., wired,using a contact pad, etc.). Alternatively, the electronics componentscan be fully integrated into the electronics subsystem 120 andconfigured to communicate with the microsensor 116, or the electronicscomponents can be split between the microsensor and the electronicssubsystem 120. The microsensor 116 can, however, comprise any othersuitable architecture or configuration.

The microsensor 116 preferably senses analyte parameters using the arrayof filaments 117, such that absolute values of specific analytes/ionscan be detected and analyzed. The microsensor 116 can additionally beconfigured to sense analyte parameters using the array of filaments 117,such that changes in values of specific analyte/ion parameters orderivatives thereof (e.g., trends in values of a parameter, slopes ofcurves characterizing a trend in a parameter vs. another parameter,areas under curves characterizing a trend, a duration of time spentwithin a certain parameter range, etc.) can be detected and analyzed. Inone variation, sensing by the microsensor 116 is achieved at a lowfrequency at discrete time points (e.g., every minute, or every hour),and in another variation, sensing by the microsensor 116 is achievedsubstantially continuously at a high frequency (e.g., every picosecond,every millisecond, every second). In one specific example for bloodchemistry analysis, the array of filaments 117 of the microsensor 116 isconfigured to sense one or more of: electrolytes, glucose, bicarbonate,creatinine, body urea nitrogen (BUN), sodium, iodide, iodine andpotassium of a user's blood chemistry. In another specific example, thearray of filaments 117 of the microsensor 116 is configured to sense atleast one of biomarkers, cell count, hormone levels, alcohol content,gases (e.g. carbon dioxide, oxygen, etc.), drugconcentrations/metabolism, pH and analytes within a user's body fluid.

As shown in FIG. 2A, the array of filaments 117 is preferably located atthe base surface of the microsensor patch 110, and functions tointerface directly with a user in a transdermal manner (e.g., inaccessing interstitial fluid) in order to sense at least one analyte/ioncharacterizing the user's body chemistry. The array of filaments 117 ispreferably arranged in a uniform pattern with a specified densityoptimized to effectively penetrate a user's skin and provide anappropriate signal, while minimizing pain to the user. Additionally, thearray of filaments 117 can be arranged in a manner to optimize couplingto the user, such that the microsensor firmly couples to the user overthe lifetime usage of the system. For example, the filaments 118 cancomprise several pieces and/or be attached to a flexible base to allowthe array of filaments 117 to conform to a user's body. In onevariation, the array of filaments 117 is arranged in a rectangularpattern, and in another variation, the array of filaments 117 isarranged in a circular or ellipsoid pattern. However, in othervariations, the array of filaments 117 can be arranged in any othersuitable manner (e.g., a random arrangement). The array of filaments 117can also be configured to facilitate coupling to a user, by comprisingfilaments of different lengths or geometries. Having filaments 118 ofdifferent lengths can further function to allow measurement of differentions/analytes at different depths of penetration (e.g., a filament witha first length can sense one analyte at a first depth, and a filamentwith a second length can sense another analyte at a second depth). Thearray of filaments 117 can also comprise filaments 118 of differentgeometries (e.g., height, diameter) to facilitate sensing ofanalytes/ions at lower or higher concentrations. In one specificexample, the array of filaments 117 is arranged at a density of 100filaments per square centimeter and each filament 118 in the array offilaments 117 has a length of 250-350 microns, which allows appropriatelevels of detection, coupling to a user, and pain experienced by theuser.

Each filament 118 in the array of filaments 117 preferably functions tosense a single analyte; however, each filament 118 in the array offilaments 117 can additionally be configured to sense more than oneanalyte. Furthermore, the array of filaments 117 can be furtherconfigured, such that a subarray of the array of filaments 117 functionsas a single sensor configured to sense a particular analyte orbiomarker, as shown in FIG. 2B. Furthermore, any configuration of subarrays of the array of filaments 117 can additionally or alternativelybe configured as one or more of: a working electrode, a counterelectrode (i.e., auxiliary electrode), and a reference electrode, forinstance, in a two-electrode cell, a three-electrode cell, or amore-than-three-electrode cell. In one variation, as shown in FIG. 2C,the array of filaments 117 of the microsensor 116 is configured as afirst working electrode 11 (corresponding to a first subarray offilaments), a second working electrode 12 (corresponding to a second subarray of filaments), a counter electrode 13 (corresponding to a thirdsubarray of filaments), and a reference electrode 14 (corresponding to afourth subarray of filaments). In a specific example of this variation,each sub array associated with the first working electrode 11, thesecond working electrode 12, the counter electrode 13, and the referenceelectrode 14, respectively, is substantially identical in morphology(e.g., area of the microsensor). Furthermore, in the specific example,each sub array has a square footprint, and the subarrays are configuredin a 2×2 arrangement to define a larger square footprint. However, thearray of filaments 117 can be configured as one or more of: a workingelectrode, a counter electrode, and a reference electrode in any othersuitable manner, and can furthermore have any other suitablemorphology(ies) and/or configuration relative to each other.

Additionally or alternatively, any sub array of the array of filaments117 can be configured to release biomaterials (e.g., therapeuticsubstances, drugs) for treating a medical condition of a user (e.g., asfacilitated by biomaterial dissolution in interstitial fluid). Multiplesubarrays of the array of filaments can then be configured to sensedifferent analytes/biomarkers, or the same analyte/biomarker.Furthermore, a subarray or a single filament 118 of the array offilaments 117 can be configured as a ground region of the microsensor116, such that signals generated by the microsensor 116 in response toanalyte detection can be normalized by the signals generated by thesubarray or single filament 118 serving as a ground region. Preferably,all subarrays of the array of filaments 117 are substantially equal insize and density; however, each subarray of the array of filaments 117can alternatively be optimized to maximize signal generation anddetection in response to a specific analyte. In an example, analytesthat are known to have a lower concentration within a user's body fluidcan correspond to a larger sub array of the array of filaments 117. Inanother example, analytes that are known to have a higher concentrationwithin a user's body fluid can correspond to a smaller subarray of thearray of filaments 117. In one extreme example, an entire array offilaments can be configured to sense a single analyte, such that themicrosensor 116 and microsensor patch 110 is configured to sense anddetect only one analyte. In another extreme example, each singlefilament in an array can be configured to detect a single analyteallowing for detection of multiple analytes within a single array (e.g.,for a 100-filament array, 100 analytes can be tested).

In other variations, a subarray of the array of filaments 117 can alsobe used to detect other physiologically relevant parameters, such aselectrophysiological signals (e.g., electrocardiogram,electroencephalogram), body temperature, respiration, and skin impedancechange (e.g., to measure hydration state or inflammatory response). Inthese other variations, the subarray can be dedicated to measuring thesephysiologically relevant parameters, which could be combined withanalyte/ion parameter measurements in order to provide meaningfulinformation to a user. As an example, the simultaneous measurement ofpotassium levels and electrocardiogram measurements, enabled bysubarrays of the array of filaments 117, can provide a more completediagnosis of cardiovascular problems or events than either measurementby itself.

A filament 118 of the array of filaments can comprise one or more of: asubstrate core, the substrate core including a base end coupled to thesubstrate, a columnar protrusion having a proximal portion coupled tothe base end and a distal portion, and a tip region coupled to thedistal portion of the columnar protrusion and that facilitates access tothe body fluid of the user; a conductive layer, isolated to the tipregion of the substrate core and isolated away from the base end and thecolumnar protrusion as an active region that enables transmission ofelectronic signals generated upon detection of an analyte; an insulatinglayer ensheathing the columnar protrusion and base end of the substratecore and exposing a portion of the conductive layer, thereby defining aboundary of the active region; a sensing layer, in communication withthe active region, characterized by reversible redox behavior fortransduction of an ionic concentration of the analyte into an electronicsignal; an intermediate selective layer superficial to the conductivelayer and deeper than the sensing layer, relative to a most distal pointof the tip region of the filament, that facilitates detection of theanalyte; an intermediate protective layer, superficial to theintermediate selective layer, including a functional compound thatpromotes generation of a protective barrier; and a selective coatingsuperficial to the intermediate protective layer, having a distributionof molecules that respond to presence of the analyte, superficial to thesensing layer. Thus, a filament can comprise one or more regions,morphologies (examples of which are shown in FIGS. 3A-3H, with elements118 a-118 h), compositions, and/or configurations as described in U.S.Pub. No. 2014/0275897, entitled “On-Body Microsensor for Biomonitoring”and filed on 14 Mar. 2014 and/or U.S. App. No. 62/025,174, and entitled“System for Monitoring Body Chemistry” and filed on 16 Jul. 2014, whichare each incorporated herein in their entirety by this reference.However, the filament can additionally or alternatively comprise anyother suitable region, composition, morphology, and/or configuration.

In general, the system 100 can include components configured to protectportions of the microsensor 116 during manufacturing, packaging, and/oruse of the system 100. For instance, a mold of impact-absorbing material17 can be positioned about the edge regions of the microsensor 116, inorder to protect edges of the microsensor 116 from damage (e.g., as abarrier). The mold of impact-absorbing material 17 can additionally oralternatively function to protect skin of the user from irritationcaused by edge-regions of the microsensor. The mold can comprise acontinuum of material (e.g., polymeric material), or can include a setof bumpers or spacers of material (e.g., polymeric material) to protectthe microsensor 116, an example of which is shown in FIG. 24.Additionally or alternatively, the material of the edge-protectingportion can be dispensed (e.g., as a gel, as an epoxy) duringmanufacture. However, the system 100 can additionally or alternativelyinclude any other suitable microsensor 116 supporting elements.

1.1.2 System—Electronics Subsystem

The electronics subsystem 120 functions to receive analog signals fromthe microsensor 116 and to convert them into digital signals to beprocessed by a microprocessor 113 of the electronics subsystem 120. Inreceiving signals, processing signals, regulating function, storingdata, and/or transmitting data, the electronics subsystem 120 preferablyincludes a microprocessor 113 interfacing with one or more of: a signalconditioning module 122, a power management module 124, an impedancedetection module 126, a storage module 127, and a transmitting unit 130,as shown in FIG. 4. However, the electronics subsystem 120 canadditionally or alternatively include any other suitable modulesconfigured to facilitate signal reception, signal processing, and datatransfer in an efficient manner.

The microprocessor 113 preferably includes memory and/or is coupled to astorage module 127 (e.g., flash storage). The microprocessor 113 canalso include and/or be coupled to a clock/watchdog module (which can beincorporated into a microcontroller unit) for control of timing betweendifferent functions of the electronics subsystem 120. The microprocessor113 functions to process received signals, enable power distribution,enable impedance monitoring, and enable data transmission from theelectronics subsystem 120, in relation to other portions of theelectronics subsystem 120 described below; however, the microprocessor113 can alternatively or additionally be configured to perform any othersuitable function.

The signal conditioning module 122 functions to preprocess signalsdetected and received using the microsensor 116, thereby producingconditioned data prior to processing at the processing subsystem 160.The signal conditioning module 122 can include one or more of: a signalmultiplexer, an analog front end, an amplifier (e.g., a variable gainamplifier), a filter (e.g., low pass filter, high pass filter, band passfilter, etc.), an analog-to-digital converter (ADC), and adigital-to-analog converter (DAC). In one variation, as shown in FIG. 4,the signal conditioning module 122 comprises a multiplexer 22 incommunication with the microsensor 116, wherein the multiplexer 22 isconfigured to communicate an output to an analog front end 23 thatinterfaces the microsensor 116 with an ADC 24 by way of a variable gainamplifier 25 coupled to a filter 26. In a specific example of thisvariation, the analog front end 23 circuitry is configured with ashifted potential different than a reference potential of the referenceelectrode 14 of the microsensor 116, wherein the shifted potential isdifferent (e.g., −2V to 2V different) from the reference potential ofthe reference electrode 14. The configuration involving a differencebetween the shifted potential and the reference potential can allow thesystem 100 to drive redox reactions at the surface of the microsensor110. However, in alternative variations of the specific example, theanalog front end (or any other element of the signal conditioning module122) can be configured with any other suitable potential relative topotentials of electrodes of the microsensor 116.

In more detail, the multiplexer 22 of the signal conditioning module 122is preferably configured to receive multiple signals from themicrosensor 116 (e.g., from subarray s of the array of filaments 117)and to forward the multiple signals received at multiple input lines ina single line at the analog front end. The multiplexer 22 thus increasesan amount of data that can be transmitted within a given time constraintand/or bandwidth constraint. The number of input channels to themultiplexer 22 is preferably greater than or equal to the number ofoutput channels of the microsensor 116, and can have any suitablerelationship between the number of input lines into the multiplexer 22,select lines of the multiplexer, and output lines from the multiplexer22. In some variations, the multiplexer 22 can include apost-multiplexer gain in order to reduce capacitance values of theanalog front end 23 coupled to the multiplexer 22, and which can also beused to limit a number of amplifiers of the electronics 120, such that asingle amplifier is coupled to the multiplexer 22 (as opposed toamplifiers coupled to each individual sensor); however, the multiplexer22 can alternatively not include any gain producing elements. In somevariations, the multiplexer 22 can additionally or alternatively includehigh frequency and/or low frequency limiting elements. However, themultiplexer 22 can additionally or alternatively be configured in anyother suitable manner. Furthermore, in alternative variations, thesignal conditioning module 122 can omit a multiplexer and/or comprise oromit any other suitable element.

In variations, an interface between the microsensor 116 and otherelements of the electronics subsystem 120 can be configured in a mannerthat prevents or otherwise reduces leakage current effects due to aredox potential of the microsensor 16 in relation to other elementselectronics subsystem 120. In a first configuration, a leakage currenteffect can result when a diode to ground (e.g., an ESD-diode to ground)is configured at an interface between the microsensor 116 and amultiplexer 22, as shown in FIG. 5A. To prevent or otherwise reduce theleakage current effect, a set of diodes 70, comprising a first diode 71(e.g., a first EST-diode) and a second diode 72 (e.g., a secondESD-diode), configured at an interface between the microsensor 116 andthe multiplexer 22 can be coupled to an element 73 (e.g., inductor,ferrite bead, resistor, etc.) that provides a high resistance totransient voltage spikes and directs any discharge through the seconddiode 72 to ground (instead of damaging the electronics subsystem 120),as shown in FIG. 5B. The multiplexer 22 can also comprise a switch 75,as shown in FIG. 5C, that allows altering of potentials within theanalog front end 23. As shown in FIG. 5C, eliminating a voltagedifference (i.e., between Vs and V2) eliminates or otherwise reducesleakage currents that can affect readings from the microsensor 110.

The power management module 124 functions to provide dynamic modulationof power transfer to and from elements of the microsensor patch 110, ina manner that enables efficient operation of the system 100. Preferably,the power management module 124 interface s with a battery 138 andelements of the transmitting unit 130 requiring power (e.g., by way of amicroprocessor 113, as shown in FIG. 4), as described in further detailbelow. Additionally, the power management module 124 can furtherinterface with an external processing element of the processingsubsystem 160, such that the power management module 124 can be at leastpartially implemented in firmware. In one such variation of the powermanagement module 124, wherein power management is achieved in firmware,the power management module 124 can be configured to anticipate powerrequirements of one or more elements, and to automatically operate atthe highest demanded power mode (e.g., voltage) required, while neverdropping below a minimum power level required by the elements. The powermanagement module 124 can also facilitate efficient switching ofcomponents to an “off” state when not needed, in order to contribute tolower current consumption. Additionally or alternatively, the powermanagement module 124 can be configured to dynamically trigger highcurrent draw sensing components (e.g., the impedance detection module126) to an “on” state, only when needed, by monitoring other systemcomponents (e.g., voltage of a counter electrode 13).

In an example, as shown in FIG. 6A, a group of elements requiringdifferent operating power levels can be coupled to the power managementmodule 124, and the power management module 124 can output power at thehighest operating power level anticipated among the elements. Disparateelements can also set a minimum level of power they require, and aselements vary their power requirements, the power management module 124can then automatically adjust power output such that a power levelprovided never drops below the lowest power level required. In thisvariation, elements of the microsensor patch 110 requiring power arethus dynamically provided with their highest demanded power level, tosubstantially limit energy wasted by the system 100 and to satisfy powerlevel requirements of all running elements. In another variation of thepower management module 124, wherein power management is achieved infirmware, the power management module 124 can be configured to detectelements requiring power, and to automatically operate at the highestdemanded power mode (e.g., voltage) required. In an example, a group ofelements requiring different operating voltages can be detected, and thepower management module 124 can output power at the highest operatingvoltage detected. As elements vary their voltage requirements, the powermanagement module 124 can then automatically adjust voltage output tomeet the highest demanded voltage. In this variation, elements of themicrosensor patch 110 requiring power are thus dynamically provided withtheir highest demanded voltage, to substantially limit energy wasted bythe system 100.

In other variations, power management can be achieved by the powermanagement module 124 without implementation in firmware, such thatpower management occurs in circuitry. In these other variations, anexample of which is shown in FIG. 6B, power management can compriseproviding a set amount of power to elements requiring power, andcompletely eliminating power transfer to elements not requiring power.The system 100 can, however, comprise any other suitable variation ofthe power management modules 124.

In relation to the power management module 124, the electronicssubsystem 120 can comprise a battery 138, which functions to serve as apower source for the electronics subsystem 120. The battery 138 ispreferably coupled to a fuel gage 38 and a charging detection module 39,each of which is coupled to the microprocessor 113 (described in furtherdetail below). The battery 138 is preferably a lithium-ion battery thatis configured to be rechargeable, but can be any appropriaterechargeable battery (e.g., nickel-cadmium, nickel metal hydride, orlithium-ion polymer). Alternatively, the battery 138 may not be arechargeable battery. Preferably, the battery 138 is configured to havea profile with a low aspect ratio, contributing to a thin form factor ofthe microsensor patch 110. However, the battery 138 can be configured tohave any appropriate profile such that the battery 130 provides adequatepower characteristics (e.g., cycle life, charging time, discharge time,etc.) for the system 100. In some variations, a thin-film battery can beintegrated with the microsensor patch 110 in order to facilitatesubstantially continuous analyte detection by the system 100,independent of the microprocessor 113 and digital electronics of theelectronics subsystem 120.

In embodiments where the battery 138 is rechargeable, the electronicssubsystem 120 can also comprise a charging coil 140 that functions toprovide inductive charging for the battery 138, and a charging detectionmodule 39, in communication with the microprocessor 113, that enabledetection of charging of the battery 138. The charging coil 140 ispreferably coupled to the battery 138 and converts energy from anelectromagnetic field (e.g., provided by an element of a base station,as described in further detail below), into electrical energy to chargethe battery 138. Inductive charging provided by the charging coil 140thus facilitates user mobility while interacting with the system 100. Inalternative variations, however, the charging coil 140 can altogether beomitted (e.g., in embodiments without a rechargeable battery), orreplaced by a connection configured to provide wired charging of arechargeable battery.

Additionally or alternatively, in some variations, the microsensor patch110 can comprise a semi-active or fully-active power cell (e.g.,implementing microelectromechanical system elements) that functions toabsorb and/or release generated energy from any one or more of: bodyheat of the user, body movement of the user (e.g., with piezoelectricelements, with capacitive elements), static voltage from the environmentof the user, light in the environment of the user (e.g., using solarcells), magnetic energy flux, galvanic differentials, and any othersuitable energy source to provide secondary backup energy for the system100.

The impedance detection module 126 is in communication with the signalconditioning module 122 and the power management module 124, andfunctions to enable detection of a proper interface between themicrosensor 116 and body fluid (e.g., interstitial fluid) of the user.In facilitating monitoring of impedance, the impedance detection module126 can thus provide signals that indicate that the microsensor patch110 is properly coupled to the user (e.g., interfacing with interstitialfluid and experiencing an ˜80% moisture environment) or improperlycoupled to the user (e.g., not interfacing properly with interstitialfluid and experiencing a low-moisture environment). Signals from theimpedance detection module 126 can further be used to trigger an errorcorrection action (e.g., notification for the user to reapply themicrosensor patch 110, automatic manipulation of the microsensor patch110 to re-establish interface with body fluid, etc.). In one variation,as shown in FIG. 4, the impedance detection module can compriseelectronic circuitry configured to communicate with the multiplexer 22,the ADC 24, and the power management module 124, in receiving animpedance signal from the microsensor 116. However, the impedancedetection module 126 can additionally or alternatively be configuredrelative to other elements of the electronics subsystem 120 in any othersuitable manner.

In generating the impedance signal, the impedance detection module 126can be configured to detect impedance between two electrodes of thearray of filaments 117 in response to an applied voltage provided incooperation with the power management module 126 and the microprocessor113. In one variation, wherein the microsensor 116 comprises a firstworking electrode 11, a second working electrode 12, a counter electrode13, and a reference electrode, the impedance detection module 126 can beconfigured to detect impedance from two of the first working electrode11, the second working electrode 12, the counter electrode 13, and thereference electrode 14, examples of which are shown in FIG. 7. In aspecific example, an applied signal can be injected into the system in aworking electrode and detected in the reference electrode 14. However inother configurations of the microsensor 116, the impedance detectionmodule 126 can be configured to detect impedance from electrodes of themicrosensor 116 in any other suitable manner.

In relation to the applied voltage used for generation and reception ofthe impedance signal (i.e., for purposes of perturbation), theelectronics subsystem 120 is preferably configured to provide an appliedvoltage waveform having a characteristic value (e.g., average value)near the operating potential of the signal conditioning module 122 ofthe electronics subsystem 120. In a variation wherein the signalconditioning module 122 (e.g., an analog front end 23 of the signalconditioning module 122) operates at a shifted potential relative to apotential of an electrode of the microsensor 116 (e.g., a referencepotential of a reference electrode), the applied voltage waveformpreferably has a characteristic value (e.g., average value) near orequal to that of the shifted potential, in order to improve stability ofthe microsensor 110 when switching back to a current sensing mode (i.e.,the primary detection mode). The offset (i.e., shifted potential) isconfigured to reduce or minimize any disruption to signal integrity whenthe microsensor 110 is switched from a current sensing mode to animpedance detection mode, and then back to a current sensing mode. In aspecific example, as shown in FIG. 8, the applied voltage waveform isshifted about a characteristic value and has a frequency from 50-200kHz, in relation to a shifted potential of the analog front end 23relative to the reference electrode 14. However, the applied voltage canalternatively have any other suitable characteristics (e.g.,characteristic voltage values, frequencies, etc.) defined in relation tothe operating potential(s) of any other suitable element of theelectronic subsystem 120 related to the microsensor 116.

In relation to triggering of a measurement using the impedance detectionmodule 126, triggering can occur with any suitable frequency (e.g., inrelation to the lifespan of usage of the system 100), any suitableregularity (e.g., at regular time intervals, at irregular timeintervals, etc.), and/or upon any suitable triggering event. In onevariation, the impedance detection module 126 can be configured toprovide an impedance signal in association with monitoring of anelectrode (e.g., monitoring voltage of the counter electrode 13) of themicrosensor 116, wherein detection of an out-of-range parameter (e.g.,voltage) of the electrode triggers the applied voltage waveform andgeneration of an impedance signal. As such, the electronics subsystem120 and the processing subsystem 160 (described further below) can beconfigured to cooperate in continuously detecting a voltage parameter ofthe counter electrode 13, and the electronics subsystem 120 can beconfigured to apply the applied voltage waveform and detect theimpedance signal when the voltage parameter of the counter electrodesatisfies a voltage threshold condition.

Additionally or alternatively, in another variation, the impedancedetection module 126 can be configured to provide an impedance signalupon initial application of the system 100 to the body of the user.Additionally or alternatively, in another variation, the impedancedetection module 126 can be configured to provide impedance signals atregular time intervals (e.g., once every hour) over the course of use ofthe system 100 by the user. Additionally or alternatively, in relationto other sensors (e.g., of a mobile computing device associated with theuser and the system 100, of a wearable computing device associated withthe user and the system 100, of the system 100, etc.) the impedancedetection module 126 can be configured to provide an impedance signal inresponse to a sensor signal that indicates performance of an action bythe user. For instance, monitoring of signals provided by anaccelerometer and/or gyroscope can be used to indicate that the user isexercising, and that an impedance measurement should be taken (e.g.,during exercise, after exercise, etc.) to ensure proper coupling of thesystem 100 to the user. In another example, monitoring of bodytemperature of the user can be used to indicate that the user isshowering, and that an impedance measurement should be to ensure propercoupling of the system 100 to the user. The impedance detection module126 can, however, be configured in any other suitable manner.

The impedance detection module 126 can further be used to generatenotifications pertaining to impedance signal measurements that indicateimproper coupling. For instance, a notification can be generated (andtransmitted to a mobile computing device of the user) in response todetection of unsuitable impedance derived from comparison between theimpedance signal and an impedance threshold condition. However, use ofthe impedance signal in performing an error correction action can beperformed in any other suitable manner.

The transmitting unit 130 functions to receive signals generated by themicrosensor patch 110 (e.g., by way of the microprocessor 113), and tointerface with at least one of a mobile computing device 150, a dataprocessing and/or storage module (e.g., a module external to an on-boardstorage module, a cloud-based computing module, etc.) by outputtingsignals based on at least one analyte parameter. The transmitting unit130 thus cooperates with other elements of the electronics subsystem 120to transmit signals based on sensed analyte parameters, which can beused to facilitate analyses of the user's body chemistry. In variations,the transmitting unit 130 includes an antenna 132, a radio 134 couplingthe antenna to the microprocessor 113, and can additionally oralternatively include a linking interface 136 (e.g., wireless or wiredinterface, as described in further detail below).

Preferably, the transmitting unit 130 and the microsensor patch 110 areintegrated as a cohesive unit; however, the transmitting unit 130 andthe microsensor patch 110 can alternatively form a modular unit, whereinone of the transmitting unit 130 and the microsensor patch 110 isdisposable, and wherein one of the transmitting unit 130 and themicrosensor patch 110 is reusable. In variations of the microsensorpatch 110 and the transmitting unit 130, elements of the microsensorpatch 110 aside from the microsensor 116 can alternatively be integratedwith the transmitting unit 130, such that the transmitting unit 130 isconfigured to be reusable and the microsensor 116 of the microsensorpatch 110 is configured to be disposable. Modularity in the system 100is described in further detail in relation to the housing 190 below.

Additionally, the transmitting unit 130 is preferably configured tooutput signals based on at least one analyte parameter characterizingbody chemistry continuously over the lifetime usage of the transmittingunit 130; however, the transmitting unit 130 can alternatively beconfigured to output signals based on at least one analyte parameter ata set of time points (e.g., minutes, hours, days). Still alternatively,the transmitting unit 130 can be configured to output signals in amanner that does not interfere with other operations (e.g., signalcollection operations) of the electronics subsystem 120. In one suchexample, the transmitting unit 130 can be configured to stop signaltransmission whenever the ADC 24 is collecting signal data from themicrosensor 116, in coordination with timing enabled by a clock/watchdogmodule associated with the microprocessor 113. In variations, thetransmitting unit 130 can be further configured to output signals upon auser prompt, and/or can comprise a variable sampling rate. For example,the sampling rate can be lower when user is asleep, higher duringactivity (e.g., exercise), higher when there is a sudden change in avalue, higher in response to other stimuli (e.g., if glucose spikes,sampling rate increases for all analytes).

The antenna 132 of the transmitting unit 130 functions to convertelectrical signals from the microsensor patch 110 into radio waves, tofacilitate communication with one or more devices external to themicrosensor patch 110 and/or transmitting unit 130 assembly (e.g., by aBluetooth Low Energy connection). The antenna 132 preferably interfaceswith a radio 134 coupled to the microprocessor 113, as shown in FIG. 4,but can additionally or alternatively interface with other elements ofthe transmitting unit 130. The antenna is preferably an omnidirectionalantenna that radiates radio wave power uniformly primarily in one plane,with the power decreasing with elevation angle relative to the plane;however, the antenna can alternatively be an isotropic antenna that hasa spherical radiation pattern. Other variations of the antenna caninclude any appropriate antenna that can be integrated with the formfactor of the transmitting unit, while providing appropriatecommunication with external devices.

Because the system 100 can transmit in configurations where the system100 is proximal/near/coupled to the body of the user, the antenna 132can be configured, with other components of the transmitting unit 130,in order to promote undisrupted signal transmission due to signalinteractions with the body of the user. For instance, one or more of thefollowing can be implemented: the antenna 132 can be decoupled from theground plane of the printed circuit board of the electronics subsystem,the antenna 132 can be positioned near an edge region of the housing 190described below, the antenna/transmitting unit 130 can have aconfiguration of DC coupling to skin of the user (e.g., therebyproviding an offset and using the body of the user as an RF ground), andany other suitable antenna design can be implemented to reduce signaldisruption.

The radio 134 functions to transmit and receive signals from the antenna132, and also facilitates communication with elements of thetransmitting unit 130 and external devices. The radio 134 and theantenna 132 can additionally or alternatively be supplemented with alinking interface 136, as described in further detail below, but canadditionally or alternatively interface with other elements of theelectronics subsystem 120.

The linking interface 136 functions to transmit an output of at leastone element of the microsensor patch 110/transmitting unit 130 assemblyto a mobile computing device 150. Additionally, the linking interface136 can function to transmit and output of at least one element of themicrosensor patch 110 and transmitting unit 130 assembly to anotherelement external to the microsensor patch 110 and transmitting unit 130.Preferably, the linking interface 136 is a wireless interface; however,the linking interface 136 can alternatively be a wired connection. In afirst variation, the linking interface 136 can include a first modulethat interfaces with a second module included in a mobile computingdevice 150 or other external element (e.g., wrist-borne mobile computingdevice, head-mounted mobile computing device), wherein data or signals(e.g., microsensor or transceiver outputs) are transmitted from thetransmitting unit 130 to the mobile computing device 150 or externalelement over non-wired communications. The linking interface 136 of thefirst variation can alternatively implement other types of wirelesscommunications, such as 3G, 4G, radio, or Wi-Fi communication. In thefirst variation, data and/or signals are preferably encrypted beforebeing transmitted by the linking interface 136. For example,cryptographic protocols such as Diffie-Hellman key exchange, WirelessTransport Layer Security (WTLS), or any other suitable type of protocolcan be used. The data encryption can also comply with standards such asthe Data Encryption Standard (DES), Triple Data Encryption Standard(3-DES), or Advanced Encryption Standard (AES). In variations with dataencryption, data can be unencrypted upon transmission to the mobilecomputing device 150 associated with the user. However, in analternative variation, data can remain encrypted throughout transmissionto a mobile computing device (associated with the user, not associatedwith the user) and unencrypted at another module of a processingsubsystem 160 (e.g., unencrypted in the cloud), wherein informationderived from analysis of the data can then be transmitted back to themobile computing device associated with the user in a secure manner. Inthis variation, a user can thus pair his/her microsensor patch 110 witha mobile computing device unassociated with the user for transmission ofencrypted data, and then later receive personalized body information athis/her own mobile computing device 150 after processing in the cloud.

In a second variation, the linking interface 136 is a wired connection,wherein the linking interface 136 includes a wired jack connector (e.g.,a ⅛″ headphone jack, a USB connection, a mini-USB connection, alightning cable connection, etc.) such that the transmitting unit 130can communicate with the mobile computing device 150 and/or an externalelement through a complementary jack of the mobile device and/orexternal element. In one specific example of the linking interface 136that includes a wired jack, the linking interface is configured only totransmit output signals from the transmitting unit 130/microsensor patch110. In another specific example, the linking interface 136 isconfigured to transmit data to and from at least one element oftransmitting unit 130/transdermal path 110 assembly and a mobilecomputing device 150. In this example, the linking interface 136 cantransmit output signals into the mobile computing device 150 through aninput of the jack of the mobile computing device 150 and can retrievedata from an output of the jack of the mobile computing device 150. Inthis example, the linking interface 136 can communicate with the mobilecomputing device 150 via inter-integrated circuit communication (I2C),one-wire, master-slave, or any other suitable communication protocol.However, the linking interface can transmit data in any other way andcan include any other type of wired connection that supports datatransfer between the transmitting unit 130 and/or microsensor patch 110,and the mobile computing device 150.

The electronics subsystem 120 can further include athermistor/potentiostat component 20, which functions to enabletemperature monitoring of skin of the user, in order to improve signalprocessing by accounting for thermal fluctuations of the body of theuser. The thermistor/potentiostat component 20 can further function toenable detection of proper application of the system 100 at the body ofthe user, based upon monitoring of the temperature of the body of theuser. As shown in FIG. 25, in one variation, the thermistor/potentiostatcomponent 20 can interface components of the microsensor 116/firsthousing portion (e.g., patch coupled to the user) and components of thesecond housing portion 196 (e.g., pod for signal acquisition andtransmission). However, variations of the thermistor/potentiostatcomponent 20 can additionally or alternatively be configured in anyother suitable manner. For instance, measurement of temperature usingthe thermistor/potentiostat component 20 can be additionally oralternatively used to assist with measurement of analyte readings (e.g.,glucose readings), in relation to other biological or physiologicalphenomena of the user (e.g., fertility, fever, diurnal variations intemperature, etc.).

As noted above, the electronics subsystem 120 can include any othersuitable module(s) and/or be configured in any other suitable manner.For instance, the electronics subsystem 120 can include or be incommunication with an actuator configured to automatically perform anaction (e.g., vibration, provision of a biasing force) that biases themicro sensor into communication with interstitial fluid of the user, inresponse to detection of unsuitable impedance derived from comparisonbetween an impedance signal and an impedance threshold condition.

1.1.3 System—Housing

The housing 190 supports the microsensor 116 and the electronicssubsystem 120, and functions to facilitate robust coupling of themicrosensor patch 110 to the user in a manner that allows the user towear the microsensor patch 110 for a sufficient period of time (e.g.,one week, one month, etc.). The housing 190 can also function to protectelements of the microsensor patch 110 from physical damage over thelifetime usage of the microsensor patch 110. Preferably, at least oneportion of the housing 190 is flexible to facilitate adhesion to theuser and compliance with skin of the user as the user moves in his/herdaily life; however, at least a portion of the housing 190 canalternatively be rigid in order to provide more robust protectionagainst physical damage. In an embodiment where a portion of the housing190 is flexible, other elements of the microsensor patch 110 can also beflexible (e.g., using a thin film battery, using flexible electronics,etc.) to facilitate adhesion to the user and compliance as the usermoves about in his/her daily life. In one variation, the housing 190 cancomprise a single unit that entirely houses the microsensor 116 and theelectronics subsystem 120. In this variation, the housing 190 can beconfigured to couple to the user using any suitable coupling mechanism(e.g., adhesive coupling mechanism, strap-based coupling mechanism,etc.). However, in other variations, the housing 190 can alternativelybe modular and comprise a set of portions, each portion configured toenable coupling of the microsensor 116 to the user and/or to houseelements of the electronics subsystem 120. Modularity of the housing 190can thus allow portions of the system 100 to be disposable and/orreusable.

In some variations, modularity of the housing 190 can include housingcomponents that are configured to break or otherwise prevent futurerecoupling after separation. For instance, with multiple housingportions, the system 100 can comprise coupled operation modes, whereinthe multiple housing portions are coupled together during use (e.g.,body chemistry monitoring), but once the system needs to be decoupledfrom the user and/or the housing portions need to be decoupled from eachother (e.g., for charging of a module of the system, etc.), one or moreof the multiple housing portions can break in a way that preventsrecoupling. In a first example, microsensor-supporting portions of thehousing 190 can be configured to break apart (e.g., an opening of afirst housing portion can comprise a perforation or other stressconcentration region operable to break apart) after otherelectronics/power management/signal transmission components of thesystem 100 are separated from the microsensor-supporting portions of thehousing 190. However, the system 100 can additionally or alternativelybe configured in any other suitable manner in relation tomodularity/reusability.

In one modular variation of the housing 190, as shown in FIG. 9, thehousing can comprise a first housing portion 191 and a second housingportion 196, wherein the first housing portion 191 is configured tofacilitate coupling of filaments of the microsensor 116 to the user, andthe second housing portion 196 is configured to house elements of theelectronics subsystem 120 and to couple the electronics subsystem 120 tothe microsensor 116 by way of the first housing portion 191. As such,the first housing portion 191 and the second housing portion 196 of thisvariation are preferably configured to mate with each other in acomplementary manner (e.g., with a male-female coupling mechanism, witha magnetic coupling mechanism, with a latch-based coupling mechanism,with a lock-and-key based coupling mechanism, etc.). In a specificexample, as shown in FIGS. 10A-10B, the first housing portion 191′includes an opening 192′, and a second housing portion 196′ isinsertable into the opening of the first housing portion in a firstconfiguration, wherein coupling between the first housing portion 191′and the second housing portion 196′ provides a hermetic seal between thefirst housing portion 191 and the second housing portion 196 (e.g., in amanner that prevents water or other fluids from passing into a regionbetween the second housing portion 196 and the first housing portion191). In more detail, as shown in FIG. 10C, the first housing portion191 can include an o-ring 193 (e.g., an o-ring co-molded onto thematerial of the first housing portion) at a perimeter of the opening192, and a perimeter region of the second housing portion 196 caninclude a recessed region 197 that interfaces with the o-ring 193 in amanner that provides a hermetic seal. As such, the o-ring 193 can bephysically coextensive with the material of the first housing portion191 near the opening 192 in order to facilitate coupling between thefirst housing portion 191 and the second housing portion 196.Alternatively, the o-ring 193 can be physically coextensive (e.g.,go-molded) on material of the second housing portion) at a regionconfigured to interface with the opening 192, or can be coupled to oneor more of the first housing portion 191 and the second housing portion196 in any other suitable manner.

In an alternative example, as shown in FIGS. 10D and 10E, the secondhousing portion 196 can include an o-ring 193 internal to the outerdiameter of the second housing portion 196, wherein the second housingportion 196 is configured in a manner that produces a crush seal whenthe second housing portion 196 is inserted into the opening of the firsthousing portion 191 (e.g., as in FIG. 10E). In this example, the firsthousing portion 191 can thus be manufactured (e.g., molded) withoutundercuts, in order to facilitate manufacturability with respect toreduced tooling complexity and cycle time.

Additionally or alternatively, the interface between the first housingportion 191 and the second housing portion 196 can be sealed using acovering 96 that adequately spans the interface/opening 192 between thefirst housing portion 191 and the second housing portion 196, in orderto prevent water or any other undesired material from entering theinterface. In variations, the covering 96 can be flexible or rigid, andcan be comprised of any suitable material or composite of materials.Furthermore, the covering 96 can be coupled to one or more of the firsthousing portion 191 and the second housing portion 196 using an adhesivecoupling mechanism or any other suitable coupling mechanics thatpromotes sealing of the opening/interface. In a specific example, thesystem 100 can include a covering 96 comprising a flexible polymer layerthat is coupled to surfaces of both the first housing portion 191 andthe second housing portion 196 proximal the opening 192, wherein theflexible polymer layer is coupled to the housing portions with anadhesive backing. However, variations of the covering 96 can beconfigured in any other suitable manner, or some variations of thesystem 100 can entirely omit a covering 96.

The first housing portion 191 preferably exposes the microsensor 116through a base surface of the first housing portion 191, an example ofwhich is shown in FIGS. 26A and 26B, such that portions of themicrosensor 116 for accessing body fluid of the user are exposed at thebase surface of the first housing portion 191. In a first variation,only microsensor filament portions operable to penetrate the body of theuser may be exposed through the base surface of the first housingportion 191. In another variation, the entire microsensor 116, includingportions that do not penetrate the body of the user can be exposed atthe base surface of the first housing portion. However, portions of themicrosensor 116 can be exposed through the base surface of the firsthousing portion 191 in any other suitable manner. In variations whereinat least a portion of the microsensor 116 is exposed at the base surfaceof the first housing portion 191, the system 100 can include a cap thatis temporarily coupled to the base surface, wherein the cap protects themicrosensor 116 from damage (e.g., in packaging, during shipping, etc.).

The first housing portion 191 can additionally or alternatively includean adhesive substrate 91 that substantially surrounds the microsensor116 and is coupled to the base surface of the first housing portion 191,wherein the adhesive substrate 91 facilitates coupling of the firsthousing portion to the user and facilitates retention of a state ofcoupling between the microsensor 116 and the user after portions of themicrosensor have been inserted into the user's body.

Prior to application of the system 100 onto the user's body, theadhesive substrate 91 of the first housing portion 191 can be coveredwith or otherwise coupled to a liner 911, as shown in FIG. 27, whereinthe liner 911 prevents the adhesive substrate 91 from prematurelysticking to objects and/or prevents the adhesive substrate 91 fromlosing its tack. The liner 911 can additionally or alternatively bedesigned to be easily separated from the adhesive substrate 91 by theuser, such that removal of the liner 911 by the user does not interferewith application of the system 100 onto the body of the user. In somevariations, the liner 911 can include multiple parts. For instance, theliner 911 can include overlapping or non-overlapping leaves, each leafconfigured to be separated from the adhesive substrate 91 independentlyof the other leaves. Alternatively, the liner 911 can be a single linerdesigned to be separated from the adhesive substrate along a path thatdoes not interfere with a process for applying the system 100 onto thebody of the user. The liner 911 is preferably configured to be separatedin a central-to-peripheral direction, in relation to the adhesivesubstrate 91. In another variation, the liner 911 can be configured tobe separated in a peripheral-to-central direction in relation to theadhesive substrate 91. However, in still other variations, the liner 911can be configured to be released from the adhesive substrate 91 in anyother suitable direction or along any other suitable path.

In a first example, as shown in FIG. 28A, the liner 911′ includes twooverlapping leaves, wherein the two overlapping leaves includes 1) afirst leaf spanning a first portion of the adhesive substrate 91 andincluding a first valley fold configured to be used as a pull-tab, and2) a second leaf spanning a second portion of the adhesive substrate 91and including a second valley fold overlapping the first valley foldconfigured to be used as a pull-tab. As such, in this example, each ofthe first leaf and the second leaf is configured to be pulled away in acentral-to-peripheral direction in relation to the adhesive substrate91. In relation to the cap described above, the first leaf and thesecond leaf can each include cutaways, such that the leaves do not touchexposed portions of the microsensor 116; however, the first leaf and thesecond leaf can alternatively be configured in any other suitablemanner.

In a second example, as shown in FIG. 28B, the liner 911′ can include asingle liner having a spiral path initiating at a central region of theadhesive substrate and terminating at a peripheral region of theadhesive substrate, wherein the central region portion of the liner hasa pull-tab to indicate that this is where separation should initiate. Assuch, in this example, the liner is configured to be pulled away in acentral-to-peripheral direction in relation to the adhesive substrate91. In relation to the cap described above, the liner can include acutaway, such that the liner does not touch exposed portions of themicrosensor 116; however, the liner can alternatively be configured inany other suitable manner.

The opening 192 of the first housing portion 191 and the second housingportion 196 can each have substantially circular footprints; however,the opening 192 and the second housing portion 196 can additionally oralternatively have any other suitable footprints or be configured in anyother suitable manner.

In the specific example, as shown in FIGS. 10A-10B, the first housingportion 191′ can comprise an adhesive substrate 91 having a microsensoropening 92, a microsensor interface substrate 93 superior to theadhesive substrate and configured to pass the microsensor 92 through themicrosensor opening 92, a coupling ring 94 configured to retain theposition of the microsensor interface substrate 93 relative to theadhesive substrate 91 and to provide an interface for mating with thesecond housing portion 196, and a flexible cover 95 ensheathing thecoupling ring 94, coupled to the adhesive substrate 91, and configuredto maintain coupling between the adhesive substrate 191, the microsensorinterface substrate 93, and the coupling ring 94. In relation to theconfiguration described above, the adhesive substrate 91 is configuredto facilitate adhesion of the microsensor patch 110 to the user at aninferior surface of the adhesive substrate, and the flexible cover 95 isconfigured to provide the opening 192′ that receives the second housingportion 192.

The second housing portion 196 of the specific example is rigid, andconfigured to form a shell about the electronics subsystem 120, whileincluding openings that provide access for a set of contacts 98 thatinterface the electronics subsystem 120 with the microsensor interfacesubstrate 93 when the first housing portion 191 is coupled to the secondhousing portion 196. In relation to the microsensor interface substrate93 of the first housing portion 191, and in relation to a circular (orotherwise axially symmetric) configuration of an interface between thesecond housing portion 196 and the opening 192 of the first housingportion 191, the microsensor interface substrate 93 of the specificexample can include a circular printed circuit board comprising a set ofconcentric ring contacts 97, as shown in FIG. 10A, that interfaceelectronics of the second housing portion 196 with filaments of themicrosensor 116. As such, the set of contacts 98 (e.g., digitalcontacts) of electronics of the second housing portion 196 can properlyinterface with the microsensor 116 in any rotational position of thesecond housing portion 196 within the first housing portion 191, asshown in FIG. 10B. In alternative variations of this specific examplehowever, orientation-unspecific coupling between the first housingportion 191 and the second housing portion 196 can be achieved in anyother suitable manner. In still alternative variations of this specificexample, the first housing portion 191 and the second housing portion196 can be configured to couple with a set orientation in order toensure proper communication between the microsensor 116 and theelectronics subsystem 120.

Some variations of the housing 190 can additionally or alternativelyinclude a coating that prevents water permeation (and/or other liquidpermeation), but allows electrical contact (e.g., for current passage)to be made between the set of concentric ring contacts 97 of the firsthousing portion 191 and contacts 98 of the second housing portion 196.In variations, the coating can include a nanocoating of colloidalsuspension of silicon oxide, which allows current passage through awaterproof layer that protects electronic components from shorting;however, the housing 190 can additionally or alternatively include anyother suitable coating. For instance, waterproofing of electronics withcoatings can additionally or alternatively be achieved using an adhesivecoating (e.g., thin film) applied to circuit board components prior toassembly. Additionally or alternatively, the coating can include ananocoating of another suitable material (e.g., paralene, etc.).

Furthermore, in relation to coupling between printed circuit board (PCB)components and components of either or both the first and the secondhousing portions 191, 196, coupling can be achieved using an adhesiveprocess (e.g., using a glue or other adhesive). Additionally oralternatively, coupling can be achieved using a thermal process (e.g., aheat staking process) to couple PCB(s) to portions of the first housingportion 191 and/or the second housing portion 196.

In variations of the housing 190 comprising a first housing portion 191and a second housing portion 196, the first housing portion 191 and thesecond housing portion 196 can be coupled together and/or coupled to theuser by way of a applicator system 180, as described in further detailbelow. Furthermore, other variations of modularity can comprise anyother suitable distribution of the microsensor 116 and elements of theelectronics subsystem 120 across portions of the housing in any othersuitable manner. For instance, in one such variation, the microsensor116, the multiplexer 22, and the analog front end 93 of the electronicssubsystem 120 can be coupled to a separate battery (e.g., a thin filmbattery) within a disposable portion of the housing 190, and otherelements of the electronics subsystem 120 can be supported by a reusableportion of the housing 190. The system 100 can, however, comprise anyother suitable distribution of elements across the housing 190 in amodular fashion.

1.2 System—Processing Subsystem

The processing subsystem 160 is in communication with the electronicssubsystem 120 and functions to generate analyses pertaining to theuser's body chemistry, and to transmit information derived from theanalyses to the user at an electronic device associated with the user.As shown in FIG. 1, the processing subsystem 160 can be implemented inone or more of: a computer machine, a remote server, a cloud computingsystem, a microprocessor, processing hardware of a mobile computingdevice (e.g., smartphone, tablet, head-mounted mobile computing device,wrist-borne mobile computing device, etc.) and any other suitableprocessing system. In one variation, the processing subsystem 160comprises a first module 161 configured to generate an analysisindicative of an analyte parameter of the user and derived from a signalstream from the microsensor 116 and an impedance signal from theelectronics subsystem 120. Additionally, in this variation, theprocessing subsystem 160 comprises a second module 162 configured torender information derived from the analysis at an electronic device(e.g., mobile computing device 150) associated with the user, therebyfacilitating monitoring of body chemistry of the user. In thisvariation, the modules of the processing subsystem 160 can beimplemented in a hardware module and/or a software module. Invariations, a software module 163 can be implemented, at least in part,as a native software application executing on a mobile computing device150 associated with the user, wherein the user has a user accountassociated with the native software application.

In more detail, the software module 163 functions to analyze an outputprovided by the transmitting unit 130 of the electronics subsystem 120,and to communicate an analysis of the output back to the user, so thatthe user can monitor his/her body chemistry. Preferably, the softwaremodule 163 analyzes at least one analyte parameter in order to determinea metric providing information about a user's body chemistry. In onevariation, the software module can determine that a body analyteparameter (e.g., glucose level) of the user is too low or less thanideal, and facilitate a behavior change in the user by providing a bodychemistry metric indicating a hypoglycemic state. In this variation, thesoftware module can additionally determine that the body analyteparameter (e.g., glucose level) of the user is within a proper rangebased on a determined metric. The software module of this variation canadditionally determine that the body analyte parameter (e.g., glucoselevel) of the user is too high and facilitate a behavior change in theuser by providing a body chemistry metric indicating a hyperglycemicstate.

In another example, the software module can analyze an output providedby the transmitting unit 130 based on a set of parameters for multipleanalytes characterizing a user's body chemistry, at a set of timepoints, and determine at least one metric based on the set of parametersat the set of time points. The software module can then determine andoutput at least one of a temporal trend in a metric, a temporal trend inan analyte parameter, absolute values of a metric, changes in value of ametric, absolute values of an analyte parameter, and changes in value ofan analyte parameter. The software module 163 in this example canfurther be configured to communicate a suggestion to the user based onan analysis determined from the set of parameters for multiple analytes.

The software module preferably incorporates at least one of user healthcondition, user characteristics (e.g., age, gender, ethnicity), and useractivity in analyzing an output provided by the transmitting unit 130.In one specific example, if a user sets a desired body glucose levelrange, which is entered into the software module, the software modulecan be configured to facilitate provision of alerts notifying the userof short-term risks (e.g., diabetic crash), long-term risks (e.g.,worsening diabetic condition), and risk of exiting the desired bodyglucose level range. In another specific example, the software modulecan compare analyte parameters and/or a metric characterizing the user'sbody chemistry to other users with similar health conditions orcharacteristics (e.g., age, gender, ethnicity). In yet another example,the software module can be able to correlate at least one analyteparameter or metric to a user activity, such that the user is providedwith information relating a value of the analyte parameter and/or metricto an activity that he or she has performed. The software module canadditionally or alternatively provide an analysis that includes anyother health- and/or user-related information that can be useful intreating, maintaining, and/or improving a health condition of a user.

As shown in FIGS. 1, 11A, and 11B, the software module can beimplemented, at least in part, as an application executable on a mobilecomputing device 150. As described above, the mobile computing device150 is preferably a smartphone but can also be a tablet, laptopcomputer, PDA, e-book reader, head-mounted computing device,smart-watch, or any other mobile device. The software module canalternatively be an application executable on a desktop computer or webbrowser. The software module preferably includes an interface thataccepts inputs from the user (e.g., user health condition, usercharacteristics, user activity), and uses these inputs in analyzing anoutput provided by the transmitting unit 130. Preferably, the softwaremodule also includes an interface that renders an analysis based onsensed analytes and/or user inputs in some form. In an example, thesoftware module includes an interface that summarizes analyte parametervalues in some manner (e.g., raw values, ranges, categories, changes),provides a trend (e.g., graph) in at least one analyte parameter or bodychemistry metric, provides alerts or notifications, provides additionalhealth metrics, and provides recommendations to modify or improve bodychemistry and health metrics. In another example, the software modulecan implement two interfaces: a first interface accessible by a user,and a second interface accessible by a health care professionalservicing the user. The second interface can provide summarized anddetailed information for each user that the health care professionalinteracts with, and can further include a message client to facilitateinteractions between multiple users and the health care professional.The software module can additionally or alternatively access a remotenetwork or database containing health information of the user. Theremote network can be a server associated with a hospital or a networkof hospitals, a server associated with a health insurance agency ornetwork of health insurance agencies, a server associated with a thirdparty that manages health records, or any other user- or heath-relatedserver or entity. The software module can additionally or alternativelybe configured to accept inputs from another entity, such as a healthcareprofessional, related to the user.

The software module 163 can additionally or alternatively execute fullyor in part on a remote server. In a first variation, the software modulecan be a cloud-computing-based application that performs data analysis,calculations, and other actions remotely from the mobile computingdevice 150. In one example of the first variation, the mobile computingdevice 150 can receive an output of the transmitting unit 130 via thelinking interface 136 and then transfer the output to the remote serverupon which the software module executes. In the first variation, signalsare preferably transferred via a wireless connection, such as aBluetooth connection, 3G or 4G cellular connection, and/or via a Wi-Fiinterne connection. In another example of the first variation, a mobilecomputing device 150 can function to transmit data to and/or receivedata from the software module. In a second variation, the softwaremodule can include a first software component executable on a mobilecomputing device 150, such as an application that manages collection,transmission, retrieval, and/or display of data. In the secondvariation, the software module can further include a second softwarecomponent that executes on the remote server to retrieve data, analyzedata, and/or manage transmission of an analysis back to the mobilecomputing device 150, wherein the first software component managesretrieval of data sent from the second software component and/or rendersof a form of the analysis on a display of the mobile computing device150. However, the software module can include any number of softwarecomponents executable on any mobile computing device 150, computingdevice, and/or server and can be configured to perform any otherfunction or combination of functions.

As shown in FIG. 12A, the software module 163 can further be integratedwith a notification module 165 configured to provide an alert ornotification to a user and/or health care professional based on theanalysis of the output. The notification module 165 functions to accessan analysis provided by the software module and to control transmissionof a notification 166 to at least one of a user and a healthcareprofession interacting with the user. In one variation, the notificationmodule 165 receives an analysis of the software module being executed ona mobile computing device 150, and generates a notification 166 basedupon the analysis. In this variation, a form of the analysis ispreferably transmitted from the software module, executing on the mobilecomputing device 150, to the notification module 165, wherein the mobilecomputing device 150 accesses the analysis either from the softwaremodule executing on the mobile computing device 150 or from the softwaremodule executing on a remote server and in communication with the mobilecomputing device 150. The notification module 165 preferably controlstransmission of the notification 166 to the user, such as by triggeringa display of the mobile computing device 150 to display a form of thenotification, or by generating and/or transmitting an email, SMS,voicemail, social media platform (e.g., Facebook or Twitter) message, orany other message accessible by the user and which contains thenotification 166. The notification module 165 can also convey thenotification 166 by triggering a vibration of the mobile device 160,and/or by altering the state (i.e., ON or OFF) of one or more lightsources (e.g., LEDs) of the mobile computing device 150. However, thenotification module 165 can alternatively manage the transmission of anyother information and function in any appropriate manner.

The notification 166 preferably contains information relevant to a bodychemistry status of the user. The notification 166 can additionallyinclude an explicit directive for the user to perform a certain action(e.g., eat, rest, or exercise) that affects the body chemistry of theuser. Therefore, the notification 166 preferably systematically andrepeatedly analyzes a body chemistry status of the user based on atleast one analyte parameter of the user and provides and alert and/oradvice to manage and monitor a user's body chemistry substantially inreal time. In one example, the notification 166 can further includeinformation related to what or how much to eat, where and how long torun, level of exertion, and/or how to rest and for how long in order toappropriately adjust body chemistry. In other examples, the notification166 can include any appropriate information relevant to monitoring abody chemistry metric of the user.

In still other examples, as shown in FIG. 12B, the notification 166 canindicate one or more of: a current level of a measured analyte (e.g.,represented in hue, represented in saturation, represented in intensity,etc. of a graphical rendering); a trending direction for the level ofthe measured analyte (e.g., represented in a feature gradient within agraphical rendering); a lower bounding level and an upper bounding levelbetween which the level of the measured analyte is traversing; atrending direction of a level of a measured analyte (e.g., representedin an arrow of a graphical rendering); a quantification of a level of ameasured analyte (e.g., represented as rendered text); a summary of alevel of a measured analyte (e.g., represented as rendered text); apercent of time within a time duration (e.g., one day) that the level ofthe measured analyte is within a target range (e.g., healthy range); andhistorical behavior of a level of a measured analyte (e.g., representedas historical “ghosting” of a rendering based upon a previous analytelevel).

Additionally or alternatively, in still other examples, as shown in FIG.12C, the notification 166 can include a graphical rendering that showsanalyte data from past to present using a line graph representation,wherein an amount (e.g., concentration) of the analyte is representedalong a first axis and time is represented along a second axis. In theseexamples, the graphical rendering can further include a “predictedregion” based upon the analysis of the processing subsystem 160, whereinthe predicted region 66 depicts a prediction of where the analyte levelwill be at a future time point, and a width of the predicted region 66indicates confidence in the prediction.

In relation to the processing subsystem 160 and analyses generated atthe processing subsystem 160, the processing subsystem 160 can becoupled to or comprise a data storage unit 170, as shown in FIG. 13. Thedata storage unit 170 functions to retains data, such as an analysisprovided by a software module, a notification 166, and/or any otheroutput of any element of the system 100. The data storage unit 170 canbe implemented with the microsensor patch 110, transmitting unit 130,mobile computing device 150, personal computer, web browser, externalserver (e.g., cloud), and/or local server, or any combination of theabove, in a network configured to transmit, store, and receive data.Preferably, data from the data storage unit 170 is automaticallytransmitted to any appropriate external device continuously; however,data from the data storage unit 170 can alternatively be transmittedonly semi-continuously (e.g., every minute, hourly, daily, or weekly).In one example, data generated by any element can be stored on a portionof the data storage unit 170 when the linking interface 136 is notcoupled to an element external to the microsensor patch 110/transmittingunit 130 assembly. However, in the example, when a link is establishedbetween the linking interface 136 and an external element, data can thenbe automatically transmitted from the storage unit 170. In otherexamples, the data storage unit 170 can alternatively be prompted totransmit stored data by a user or other entity. Operation modes relatedto device pairing and information transfer are further described inrelation to the base station of Section 1.4 below.

1.3 System—Applicator

As shown in FIG. 1, the system 100 can further comprise a applicatorsystem 180, which functions to facilitate application of at least one ofthe microsensor patch 110 and the transmitting unit 130 onto a bodyregion of the user. The applicator system 180 preferably accelerates thea portion of the housing with the microsensor 116 toward skin of theuser, thereby causing the microsensor 116 to penetrate skin of the userand sensing regions of the microsensor to access interstitial fluid ofthe user. However, the applicator system 180 can additionally oralternatively facilitate coupling of the microsensor 116 to the userusing one or more of: skin stretching, skin permeabilization, skinabrasion, vibration, and/or any other suitable mechanism, variations ofwhich are shown in FIGS. 14A-14C.

In variations, as shown in FIG. 15, the applicator system 180 caninclude a first applicator portion 81 comprising a coupling interface811; a second applicator portion 82 comprising a retainer 821; anelastic coupler 83 between the first applicator portion 81 and thesecond applicator portion 82; and a trigger 84 operable between a loadedmode 84 a and a released mode 84 b; wherein, in the loaded mode, theelastic coupler is in a first compressed state between the firstapplicator portion and the second applicator portion, the firstapplicator portion is retained by the retainer of the second applicatorportion, and the coupling interface is coupled to the second housingportion; and wherein, in the released mode, the elastic coupler is in asecond compressed state (e.g., a state of lower compression ornon-compression) between the first applicator portion and the secondapplicator portion, the first applicator portion is released from theretainer of the second applicator portion, and the coupling interface isuncoupled from the second housing portion, with the microsensor portionscoupled to the user.

These variations of the applicator system 180 function to provide amechanism that promotes proper application of the microsensor patch 110at the body of the user. As such, these variations are configured forease of use and/or error-preventing use in relation to one or more of:transitioning the applicator system into a loaded mode; initialpositioning of the microsensor patch 110 at portions of the applicatorsystem; positioning the applicator system 180 with the microsensor patch110 at a body region prior to insertion of microsensor portions into thebody; transitioning the applicator system from the loaded mode to thereleased mode, thereby properly inserting microsensor into the body ofthe user; and moving the applicator system 180 away from the body of theuser.

1.3.1 Applicator—First Applicator Portion

The first applicator portion 81 functions to reversibly retain themicrosensor patch 110 prior to coupling of the microsensor patch 110 tothe user. The first applicator portion 81 can thus function to retainthe microsensor patch as the microsensor patch is loaded and thenaccelerated toward the body of the user for microsensor insertion. Then,the first applicator portion 81 can release the microsensor patch 110such that the microsensor patch 110 can be left at the body of the user.

As such, the first applicator portion 81 can include a couplinginterface 811 that couples to one or more portions of the microsensorpatch 110 prior to insertion. The coupling interface 811 can include: asuction interface operable to temporarily retain a surface of themicrosensor patch 100 using negative pressure and by forming a temporaryseal with the surface of the microsensor patch 100. Additionally oralternatively, the coupling interface 811 can interface with themicrosensor patch 110 by any any one or more of: an adhesive interfaceformed by an adhesive region of the first applicator portion and/or themicrosensor patch 110; a magnetic interface between magnetic regions ofthe first applicator portion and the micro sensor patch 110; a lockinginterface between the first applicator portion and the microsensor patch110, a press-fit interface between the first applicator portion and themicrosensor patch 110; and any other suitable interface between thefirst applicator portion and the microsensor patch.

The coupling interface 811 preferably couples to the second housingportion 196, which as described above, supports the electronicssubsystem 120 and is insertable into an opening of the first housingportion 191. However, the coupling interface 81 can alternatively coupleto the first housing portion 191 and/or to both the first housingportion 191 and the second housing portion. In a specific example, thecoupling interface 811 comprises a suction interface that couples to asurface of the second housing portion 196 opposing a second surface ofthe second housing portion 196 that interfaces with electronics of thefirst housing portion 191; however, variations of the specific examplecan be configured in any other suitable manner.

In variations of the coupling interface 811 including a suctioninterface, the coupling interface 811 can further include a ventingchannel having a first opening into a concave portion of the suctioninterface (that couples to the microsensor patch) and a second openingat a distal end. The venting channel facilitates release of themicrosensor patch 110 from the applicator system 180 during and/or afteracceleration of the microsensor patch toward the body of the user. Theventing channel preferably has a shaft, an example of which is shown inFIGS. 16A and 16B, and a pathway through the shaft that connects thefirst opening to the second opening. As described below, the secondopening of the venting channel preferably interfaces with a sealinginterface at one or more of the second applicator portion 82 and thetrigger 84 of the applicator system 180 in order to provide 1) a sealedstate that supports coupling between the microsensor patch 110 and theapplicator system 180 and 2) an unsealed state that supports uncouplingbetween the microsensor patch 110 and the applicator system 180.However, the venting channel 86 can alternatively be configured in anyother suitable manner.

1.3.2 Applicator—Second Applicator Portion

The second applicator portion 82 functions to support the firstapplicator portion 81, the elastic coupler 83, and the trigger 84, andfunctions to cooperate with one or more portions of the applicatorsystem 110 to reversibly lock the first applicator portion 81 into placeand to release the first applicator portion 81 to accelerate amicrosensor patch 110 coupled to the first applicator portion 81 along apath toward the body of the user. The second applicator portion 82 canthus circumscribe or otherwise surround the first applicator portion 81in a manner that controls a path of motion of the first applicatorportion 81 within the second applicator portion 82. However, any othersuitable relationship can exist between the first applicator portion 81and the second applicator portion 82, such that acceleration of themicrosensor patch 110 toward the body of the user occurs as desired.

In relation to retention of the first applicator portion 81 (with thecoupled microsensor patch 110) by the second applicator portion 82, thesecond applicator portion 82 can include or be coupled to a retainer 821that provides a mechanism for reversibly locking the first housingportion 81 with the second housing portion 82 (e.g., during the loadingmode described below).

The retainer 821 can include a mechanical latching mechanism, that, whenengaged by the first housing portion 81, retains the position of thefirst housing portion in a loaded mode; then, with activation of thetrigger 84 described below disengages the latching mechanism to releasethe first housing portion 81. In specific examples, the retainer canthus include one or more of: a wedge-shaped protrusion biased laterallytoward a corresponding recessed region of the first housing portion 81,whereby the wedge-shaped protrusion engages the recessed region as thefirst housing portion 81 transitions into the loaded mode; aram-and-catch mechanism whereby twisting of at least one of the secondhousing portion 82 and the first housing portion 81 engages a retainingregion of the retainer 821; and any other suitable mechanical latchingmechanism. In more detail, a ram-and-catch mechanism (or other twistingmechanism) can be used, in combination with a elastic component (asdescribed below), to adjust the acceleration of the first applicatorportion 81, with the microsensor patch 110, toward the body of the user.Such an adjustment can be based upon an amount of potential energystored in a spring that is compressed by the rotation mechanism, or anyother suitable mechanism, and can be used to ensure proper insertion ofthe microsensor for a variety of skin types or user demographics.

The retainer 821 can additionally or alternatively include a magneticretention mechanism that reversibly retains a position of the firsthousing portion 81 relative to the second housing portion 82. Themagnetic retention mechanism can include a magnet of a first polaritycoupled to the second applicator portion 82 that interfaces with amagnet of a second polarity coupled to the first applicator portion 81,such that the two magnets provide a configuration that reversiblyretains the first housing portion 81 in position relative to the secondhousing portion 82. Alternatively, at least one magnet of the magneticretention mechanism can include an electromagnetic element. In aspecific example, as shown in FIGS. 17A and 17B, the magnetic retentionmechanism can interface with a coil element that passes current in amanner where the current magnitude affects an acceleration profile ofthe first housing portion 81, with the coupled microsensor patch 110,toward the body of the user. This mechanism is described in furtherdetail in relation to the elastic coupler 83 below.

In variations, the second applicator portion 81 can be composed of apolymeric material (e.g., plastic), a metallic material, and/or anyother suitable material. In variations of the applicator system 180incorporating mechanical mechanisms, the second applicator portion 81can be at least partially composed of plastic. In variations of theapplicator system 180 incorporating magnetic and/or electromagneticmechanisms, the second applicator portion 81 can be at least partiallycomposed of a metal (e.g., steel, etc.). However, any applicator portioncan additionally or alternatively be composed of any other suitablematerial.

1.3.3 Applicator—Support Elements and Other Elements

The applicator system 180 can also include an elastic coupler 83 betweenthe first applicator portion 81 and the second applicator portion 82,wherein the elastic coupler 83 functions to store potential energy inthe loaded mode of the trigger, which can be released to accelerate thefirst housing portion 81, with the microsensor patch 110, toward thebody of the user. In variations wherein the first applicator portion 81is situated within the second applicator portion 82, the elastic coupler83 can be positioned such that translation of the first applicatorportion 81 within the second applicator portion 82 adjusts a state ofcompression of the elastic coupler, thereby transitioning between astate of high potential energy in the loaded mode and a state of lowpotentially in the released mode, as described below. In a specificexample, as shown in FIGS. 15, 16A, and 16B, the elastic coupler 83 canreside within a space laterally between a venting channel 86 of thefirst applicator portion 81 and an interior wall of the second housingportion, wherein the elastic coupler 83 is retained in position ateither a base surface of the venting channel 86 of the first applicatorportion 81 or a base surface of the second applicator portion 82;however, the elastic coupler 83 can additionally or alternatively beconfigured relative to the first applicator portion 81 and the secondapplicator portion 82 in any other suitable manner.

The elastic coupler 83 can include a spring with a suitable spring forcein relation to storage of a maximum amount of potential energy toprovide proper acceleration of the microsensor patch 110 toward the bodyof the user. Additionally or alternatively, the elastic coupler 83 cancomprise any other suitable material that can transition between a stateof high potential energy and low potential energy. In other variations,the elastic coupler 83 can include a pair of magnets with like polarityoriented toward each other, an elastomeric element, or any othersuitable component that stores and releases potential energy.

As indicated above, in some variations wherein the second applicatorportion 82 includes or is coupled to a magnet, the applicator system 180can further include a coil of conductive material that passes current ina manner that causes an interaction between a magnetic field formed bythe current and the magnet. In a specific example, as shown in FIGS. 17Aand 17B, the elastic coupler 83 can be replaced or in some mannersupplemented by a coil of wire (e.g., voice coil) coupled to a currentsource and operable to pass a desired amount of current, therebyaffecting acceleration parameters (e.g., a velocity profile) of thefirst applicator portion 81, with the microsensor patch 110, toward thebody of the user. As such, the second applicator portion can be operablebetween different modes, each mode associated with a different amount ofcurrent passage, wherein the current magnitude changes accelerationparameters of the first applicator portion 81, with the microsensorpatch 110, toward the body of the user.

In still other variations, however, the elastic coupler 83 canadditionally or alternatively include or replaced with any othersuitable element that promotes an acceleration of the first applicatorportion 81, with the microsensor patch 110, toward the body of the user.In one alternative example, the first applicator portion can bepneumatically driven using compressed air; however, any other suitablemechanism can be incorporated.

As indicated above, in some variations, the applicator system 180 caninclude a trigger 84 operable between a loaded mode 84 a and a releasedmode 84 b, wherein the trigger 84 functions to enable release of thefirst applicator portion 81 to accelerate the microsensor patch 110toward the body of the user. The trigger 84 can be mechanicallycontrolled or electrically controlled. For instance, in a firstvariation, the trigger 84 can be entirely mechanical and used totransition the retainer 821 of the second applicator portion 82 into aconfiguration that unlatches the first applicator portion 81 from thesecond applicator portion 82, allowing the compressed elastic coupler 83to be released and accelerate the first applicator portion 81, with themicrosensor patch 110, toward the user. In a second variation, thetrigger 84 can be electronic and, when activated, allow current to passthrough a conductive coil about a magnet of the second applicatorportion 82, thereby generating a magnetic field that interacts with themagnet and creating a driving force to accelerate the first applicatorportion 81, with the microsensor patch 110, toward the user. However,other variations of the trigger 84 can be configured in any othersuitable manner, some examples of which are described in Sections 1.3.4and 1.3.5 below.

The applicator system 180 can additionally or alternatively include anyother suitable support elements. For instance, the applicator system 180can include components that support the microsensor patch 110 and/or theapplicator system 180 against the skin of the user prior to coupling ofthe microsensor to the user. In one variation, the applicator system 180can include a compressible support material situated behind the couplinginterface/suction interface of the first applicator portion 81, whereinthe compressible support material complies with the user's body duringthe process of coupling the microsensor patch 110 to the user's body.The applicator system 180 can additionally or alternatively includestructures that obscure the microsensor patch 110 from the user's viewduring the insertion process, in order to prevent apprehension of theuser during the insertion process. Additionally or alternatively theapplicator system 180 can include noise-dampening elements operable toprevent apprehension of the user during the insertion process.Additionally or alternatively, the applicator system 180 can include anaudio detection element (e.g., a microphone coupled to an element of theapplicator system) operable to detect a sound output from the elasticcoupler 83 during a transition from the loaded mode to the releasedmode, thereby facilitating assessment of proper The system can, however,include any other suitable element(s).

1.3.4 Applicator—Specific Examples

In a first specific example, as shown in FIGS. 16A and 16B, theapplicator system 180′ includes a first applicator portion 81′ includinga suction interface 811′ coupled to a venting channel 86′ with anopening 87′; a second applicator portion 82′ including a retainer; aspring 83′ between the first applicator portion 81′ and the secondapplicator portion 82′; and a trigger 84′ including a sealing interface88′, the trigger 84′ operable between a loaded mode 84 a′ and a releasedmode 84 b′; wherein, in the loaded mode, as shown in FIG. 16A, theelastic coupler is in a first compressed state between the firstapplicator portion and the second applicator portion, the firstapplicator portion is retained by the retainer of the second applicatorportion, and the suction interface is coupled to the second housingportion with the opening of the venting channel sealed by the sealinginterface. As shown in FIG. 16A, transitioning to the loaded mode 84 a′can be facilitated using an example of the base station 5 described insection 1.4 and shown in FIGS. 1 and 16A, wherein the base station 5includes a recessed platform for receiving and positioning the firsthousing portion 191 within a substantially horizontal plane. In thisexample, the recessed platform includes a central opening into a cavity,wherein the cavity provides clearance for portions of the microsensor116 coupled to the first housing portion 191, and wherein the cavityincludes a charging slot that can accept units of the second housingportion 196 for charging (e.g., even when the first housing portion 191is positioned at the recessed platform). As such, the base station 5 caninclude a charging station within the cavity and a platform, such thatthe base station 5 facilitates loading of a patch assembly and chargingof a battery of the second housing portion. Then, as shown in FIG. 16A,pressing the second applicator portion 82′ downward can transition theapplicator 180′ to the loaded mode 84 a′ by way of a trigger ring 2 ofthe second applicator portion 82′ that translates upon being compressedby a recessed ring in the base station 5 that is concentric with thetrigger ring 2.

After the applicator 180′ is in the loaded mode 84 a′, it can then betransitioned to the released mode 84 b′, wherein, in the released mode,as shown in FIG. 16B, the spring 83′ is in a second compressed state(e.g., a state of low compression) between the first applicator portion81′ and the second applicator portion 82′, the first applicator portionis released from the retainer 821′ of the second applicator portion, thesuction interface 811′ is released from the second housing portion withthe opening 87′ of the venting channel 86′ unsealed by the sealinginterface 88′, and microsensor portions of the body chemistry monitorare coupled to the user. In the specific example, pressing the secondapplicator portion 82′ downward against the user's skin can transitionthe applicator 180′ to the released mode 84 b′ by way of the triggerring 2 of the second applicator portion 82′ that translates upon beingcompressed against the user's skin. In variations of this specificexample, the trigger ring can have an adjustable set position thataffects a travel distance between the loaded patch assembly and skin ofthe user, such that the acceleration profile of the applicator 180′ canbe adjusted depending on specific needs of the user. However, thetrigger ring can alternatively be adjusted in any other suitable manner.In the specific example, the velocity of the microsensor 116 upon impactcan be between 3 and 15 m/s; however, the velocity can alternatively beany other suitable velocity to provide coupling between the microsensor116 and skin of the user.

In a broader use case for the applicator system 180′ described above,the microsensor patch 110 can be loaded into the applicator system 180with the second housing portion 196 coupled to a suction interface ofthe first housing portion, wherein in the loaded mode the ventingchannel 86 is sealed by a sealing interface of the second applicatorportion 82/trigger 84. An adhesive portion of the first housing portion191 can then be exposed, and the applicator system 180 can bepositioned, in the loaded mode 84 a and with the microsensor exposed andfacing the body of the user. Then, the trigger 84 can be activated totransition the applicator system 180 to the released mode 84, therebyusing converted potential energy from the compressed spring of theloaded mode 84 a to accelerate portions of the microsensor into the bodyof the user. However, variations of the use case described above can beconfigured in any other suitable manner.

In a second specific example, as shown in FIGS. 17A and 17B, theapplicator system 180″ includes a first applicator portion 81″ includinga coupling interface 811″ that couples to the microsensor patch bysuction; a second applicator portion 82″ composed of steel and includinga magnet 89″; a spring 83″ between the first applicator portion 81″ andthe second applicator portion 82″; a coil 88″ operable to pass currentand interact with the magnet 89″; and a trigger 84″ operable between aloaded mode 84 a″ and a released mode 84 b″; wherein, in the loadedmode, as shown in FIG. 17A, the elastic coupler is in a first compressedstate between the first applicator portion and the second applicatorportion, the first applicator portion is retained by the retainer of thesecond applicator portion, and the coupling interface is coupled to themicrosensor patch; and wherein in the released mode, as shown in FIG.17B, the spring 83″ is in a second compressed state (e.g., a state oflow compression) between the first applicator portion 81″ and the secondapplicator portion 82″, the first applicator portion is released fromthe retainer 821′ of the second applicator portion with passage ofcurrent through the coil 88″, the coupling interface 811″ is releasedfrom the second housing portion 82″, and microsensor portions of thebody chemistry monitor are accelerated into to the user.

In a use case for the applicator system 180″ described above, themicrosensor patch 110 can be loaded into the applicator system 180″ withthe second housing portion 196 coupled to the coupling interface of thefirst housing portion. An adhesive portion of the first housing portion191 can then be exposed, and the applicator system 180″ can bepositioned, in the loaded mode 84 a and with the microsensor exposed andfacing the body of the user. Then, the trigger 84 can be activated totransition the applicator system 180 to the released mode 84 withpassage of current through the coil 88″, thereby using electromagneticinteractions between the magnet 89″ and the coil 88 to accelerateportions of the microsensor into the body of the user. However,variations of the use case described above can be configured in anyother suitable manner

However, variations of the specific examples and/or use cases describedabove can be configured in any other suitable manner. For instance, somevariations of the applicator system 180 can include speaker components(or other components) operable to generate audible signals (or othersignals, such as light signals, haptic signals, etc.) indicative ofcorrect or incorrect application of the microsensor at the user's body.

1.3.5 Applicator—Other Variations

In another variation, as shown in FIG. 18A, the applicator system 180′can be incorporated into a first housing portion 191 of a housing 190 ofthe system 100 and can comprise an elastic pin 181 (e.g., spring-loadedpin) configured to complement a recess of a second housing portion 196.In this variation, a normal force applied to a broad surface of thesecond housing portion 196 initially causes the elastic pin 181 toretract, and rebounding of the elastic pin 181 into the recess of thesecond housing portion 196 biases and accelerates the microsensor 116into the skin of the user.

In another variation, as shown in FIG. 18B, the applicator system 180″implements elastic portions of the housing 190, which can be used toretract a housing portion with the microsensor 116 and to release thehousing portion, thereby accelerating the microsensor 116 into skin ofthe user.

In another variation, the applicator system cooperates with a firsthousing portion 191 and a second housing portion 196, wherein theapplicator system comprises a first applicator portion configured tosurround the housing 190 and interface with the second housing portion196, and a second applicator portion configured to accelerate the secondhousing portion toward skin of the user. In a first specific example ofthis variation, as shown in FIG. 19A, the applicator system 180 acomprises a ram-and-catch mechanism, wherein twisting of a rotatablecomponent 83 of the applicator system 180 a transitions a plunger 184 ofthe applicator system 180 a from a resting configuration 84 a to aloaded configuration 84 b, as shown in FIGS. 19B and 19C, and pushing ofthe rotatable component 83 of the applicator system 180 a releases theplunger 184 back to the resting configuration 84 a (as shown in FIG.19D), thereby accelerating the microsensor 116 toward skin of the userduring application of the microsensor patch 110 to the user. In moredetail, in the first specific example, twisting of the rotatablecomponent 83 transitions the plunger 184 along ramped surfaces 85 of theapplicator system 180 a to the loaded configuration 84 a, where theplunger 184 rests on triggers 86 of the applicator system 180 a. Then,as shown in FIG. 19D, pressing of the rotatable component 83 provides anoutward biasing force on the triggers 86 (e.g., due to wedge-shapedmorphology of the triggers that interacts with a complementary portionof the rotatable component 83), thereby releasing the plunger 184 to theresting configuration 84 a. In this specific example, a set of ribs 87coupled to a wall of the applicator system 180 surrounding the plunger184 maintain plunger alignment.

In a second specific example of this variation, as shown in FIG. 20, theapplicator system 180 b comprises an elastic component 89 housed withinand coupled to a translating component 88 of the applicator system 180b, wherein the translating component 88 comprises a plunger 184′ and isconfigured to translate along a first axis. The applicator system 180 bfurther comprises a trigger 188 coupled to a biasing spring 189 andconfigured to translate along a second axis perpendicular to the firstaxis, between a holding position 188 a and a releasing position 188 b.In the second specific example, the translating component 88 is biasedin holding position 188 a, and pushing of the translating component 88places a lateral biasing force on the trigger 188 against the biasingspring 189 (e.g., due to wedge-shaped morphology of the trigger 188 thatinteracts with a complementary portion of the translating component 88),thereby releasing the plunger 184′ to accelerate the microsensor 116toward skin of the user. In pushing the translating component 88,compression of the elastic component 89 creates a reverse biasing forcethat automatically releases the translating component 88 toward theresting configuration 88 a.

The applicator system 180 can alternatively be configured to receive themicrosensor patch 110, to stretch the skin of the user isotropically intwo dimensions to facilitate application, and to push the microsensorpatch 110/transmitting unit 130 assembly onto the user's stretch skin.Still alternatively, the applicator system 180 can include any othersuitable applicator, variations and examples of which are described inU.S. App. No. 62/025,174 entitled “System for Monitoring Body Chemistry”and filed on 16 Jul. 2014. Still other variations of the system 100 canentirely omit a applicator system 180.

1.4 System—Base Station

As shown in FIG. 1, the system can include a base station 5 thatfunctions to receive the microsensor patch 110 (e.g., within a secondhousing portion 196). In receiving the microsensor patch 110, the basestation 5 can include alignment elements 6 (e.g., protrusions, recesses,magnetic alignment elements, etc.) that facilitate alignment of themicrosensor patch 110 within the base station, as shown in FIG. 18A. Thebase station 5 can additionally or alternatively facilitate charging ofa rechargeable battery of the microsensor patch 110 by includingelements that generate an electromagnetic field that interacts with acharging coil coupled to the battery, thereby charging the battery 138.In more detail, as described above, the base station 5 can include acavity with a slot that accepts the second housing portion 196 (or anyother portion of the system 100 containing the battery) for charging,where by contacts of the charging unit can detect a feedback loopbetween the an analog front end (AFE) circuit of the second housingportion 196 and charging contacts, in order to initiate charging. Thebase station 5 can additionally or alternatively be used to transitionthe microsensor patch between different operational states, in relationto data transfer between the microsensor patch 110, a mobile computingdevice 150 associated with the user, and modules of a processingsubsystem 160 (e.g., cloud module) as shown in FIGS. 21A and 21B. In afirst operation mode 5 a, the transmitting unit 130 of the microsensorpatch 110 and the mobile computing device 150 can pair/bond only whenthe second housing portion 196 of the microsensor patch 110 is incommunication with the base station 5 (e.g., aligned within the basestation 5). Thus, in the first operation mode 5 a, the microsensor patch110 can transmit and receive data (e.g., comp act raw data compoundedinto a plurality of bits over Bluetooth communication). In a secondoperation mode 5 b wherein the microsensor patch 110 is not incommunication with the base station 5, the microsensor patch 110 can beconfigured to only transmit data (but not receive data), therebyreducing energy usage, preventing man-in-the-middle attack, andpreventing tampering. As such, the second operation mode 5 b preventsreading of data from the microsensor patch 110 by a fraudulent entity,without gaining physical access to the microsensor patch 110.

The operation modes of the system 100 enabled by the microsensor patch,the base station 5, the mobile computing device 150, and the processingsubsystem 160 are further detailed in FIGS. 21A and 21B and 22. Inrelation to pairing with the microsensor patch 110 in the firstoperation mode 5 a, the mobile computing device 150 functions to provideone or more of: data relay, data visualization, data storage,notification, and action functions (e.g., as described in relation tothe software module 163 described above). In communicating informationbetween the mobile computing device 150 and a cloud module of theprocessing subsystem 160, the mobile computing device 150 can beconfigured to transmit raw data in Javascript Object Notation (JSON)format (or any other suitable format) to be processed in the cloud, andanalyte data, notifications, and alerts (e.g., as derived from ananalysis) can be transmitted back to the mobile computing device 150 inJSON format (or any other suitable format). The cloud module of theprocessing subsystem 160 can thus serve to enable authentication of theuser (e.g., in association with a user account of a native application)and/or data, data storage, data processing, notification, and predictionfunctions, as described in relation to the processing subsystem 160described above. Thus, the system 100 is configured for fault tolerance,wherein the microsensor patch 110 stores data when faulty operation ofthe mobile computing device 150 occurs, and failure of the processingsubsystem 100 results in data storage at the mobile computing device.The system 100 can, however, be configured in any other suitable manner.

As shown in FIG. 21B, the base station 5 and the applicator system 180can be configured to couple together, thus facilitating portability ofthe base station 5 and applicator system 180. However, the base station5, applicator system 180, and microsensor 110 can alternatively beconfigured to couple or not couple together in any other suitablemanner.

1.5 System—Calibration

The microsensor patch 110 is preferably calibrated to prevent signaldegradation and to mitigate the effects of transient effects experiencedduring analyte sensing. The primary sensing mechanism is potentiometricfor small analytes (e.g., potassium, sodium, calcium), and amperometricfor large molecules (e.g., glucose, lactic, creatinine). In a firstvariation, the microsensor patch 110 passively detects analytes bydetecting an impedance and/or capacitance change, as well as a voltagechange when an analyte or analyte concentration contacts the microsensor116. Calibration can occur by normalizing sensing measurements relativeto a grounded portion of the microsensor 116, such as a referenceelectrode.

In a second variation, the microsensor patch 110 can implement activeimpedance calibration, wherein a drive voltage is implemented by theelectronics subsystem 111 of the microsensor patch 110, and voltage andimpedance and/or capacitance changes are detected. The drive voltage ispreferably applied in a sinusoidal pattern, but can alternatively beapplied in any appropriate pattern. In the second variation, sensedanalytes or analyte concentrations are characterized by changes inimpedance, and noise is characteristically distinguished from analytedetection by monitoring changes in voltage unaccompanied by changes inimpedance or capacitance. The second variation thus employs aconductometric measurement to calibrate the microsensor patch 110.Impedance measurements can also be used to address shift in a referenceelectrode (e.g., in the first variation described above).

In a third variation, the microsensor patch 110 can employ injection ofa volume of a calibration solution with a known concentration of atleast one analyte, in order to calibrate the microsensor patch 110. Inan example of the third variation, the calibration solution can have aknown concentration of at least one analyte, such that changes (e.g.,changes in electrical parameters) detected by the microsensor patch 110in response to the calibration solution can be used to normalizemeasurements resulting from sensed analytes or analyte concentrationsoccurring after injection of the volume of calibration solution. In thethird variation, the calibration solution can be injected automaticallyand periodically over the lifetime usage of the transdermal patch;however, the calibration solution can alternatively be injected whenprompted by a user or other entity.

In a fourth variation, the microsensor patch 110 can include a membranecomprising a known concentration and/or release profile of at least oneanalyte, in order to calibrate the microsensor patch 110. In an exampleof the fourth variation, the membrane can have a known concentration andrelease profile of at least one analyte, such that changes (e.g.,changes in electrical parameters) detected by the microsensor patch 110in response to the membrane can be used to normalize measurementsresulting from sensed analytes or analyte concentrations. In the fourthvariation, the membrane can be a degradable membrane, such thatdegradation of the membrane over time releases analytes from themembrane. Alternatively, the membrane can be manufactured with specificporosity, contributing to a certain analyte release profile.

In a fifth variation, the microsensor patch 110 can include a coating ora cap comprising a soluble species (e.g., analyte/ion) with a well-knownsolubility, in order to calibrate the microsensor patch 110. In anexample of the fifth variation, the soluble species maintains a knownconcentration of the species within the vicinity of a filament that canbe used to normalize and/or calibrate a signal. Examples of solublespecies include low solubility, biocompatible calcium salts, such ascalcium carbonate, calcium phosphate, and dicalcium phosphate forcalcium sensing. Other suitable soluble species can be used to calibrateother analytes.

In alternative variations, the microsensor patch 110 can use any othersuitable calibration method. For instance, the transdermal patch can bepre-staged, prepped, loaded, or activated to have a set calibrationstate enabling calibration of the system after application to the userwithin a desired period of time (e.g., an 85 mg/dl calibration stateequilibrated after insertion within a period of 2 hours).

As a person skilled in the art will recognize from the previous detaileddescription and from the figures and claims, modifications and changescan be made to the described embodiments, variations, and examples ofthe system 100 without departing from the scope of the system 100.

2. Method

As shown in FIG. 23, a method 200 for monitoring body chemistry of auser comprises: receiving a second housing portion into an opening of afirst housing portion S210, the first housing portion supporting amicrosensor including a first working electrode, a second workingelectrode, a reference electrode, and a counter electrode, and thesecond housing portion supporting an electronics subsystem configured toreceive a signal stream from the microsensor; after interfacing with thesecond housing portion, accelerating the second housing portion towardskin of the user S220, thereby delivering sensing regions of themicrosensor into interstitial fluid of the user; generating an impedancesignal, from two of the first working electrode, the second workingelectrode, the reference electrode, and the counter electrode, inresponse to applying a voltage, near a shifted potential different thana reference potential of the reference electrode S230, wherein theshifted potential is associated with a signal conditioning module of theelectronics subsystem; at a processing system in communication with theelectronics subsystem, receiving the signal stream and the impedancesignal S240; at the processing system, generating an analysis indicativeof an analyte parameter of the user and derived from the signal streamand the impedance signal S250; and transmitting information derived fromthe analysis to an electronic device associated with the user, therebyfacilitating monitoring of body chemistry of the user S260.

The method 200 functions to provide continuous monitoring of a user'sbody chemistry through reception and processing of signals associatedwith of one or more analytes present in the body of the user, and toprovide an analysis of the user's body chemistry to the user and/or anentity (e.g., health care professional, caretaker, relative, friend,acquaintance, etc.) associated with the user. Alternatively, the method200 can function to detect a user's body chemistry upon the user'srequest or sporadically, and/or can provide an analysis of the user'sbody chemistry only to the user. The method is preferably implemented,at least in part, using an embodiment, variation, or example of elementsof the system 100 described in Section 1 above; however, the method 200can additionally or alternatively be implemented using any othersuitable system.

Variations of the system 100 and method 200 include any combination orpermutation of the described components and processes. Furthermore,various processes of the preferred method can be embodied and/orimplemented at least in part as a machine configured to receive acomputer-readable medium storing computer-readable instructions and/orin the cloud. The instructions are preferably executed bycomputer-executable components preferably integrated with a system andone or more portions of a control module and/or a processor. Thecomputer-readable medium can be stored on any suitable computer readablemedia such as RAMs, ROMs, flash memory, EEPROMs, optical devices (CD orDVD), hard drives, floppy drives, or any suitable device. Thecomputer-executable component is preferably a general or applicationspecific processor, but any suitable dedicated hardware device orhardware/firmware combination device can additionally or alternativelyexecute the instructions.

The FIGURES illustrate the architecture, functionality and operation ofpossible implementations of systems, methods and computer programproducts according to preferred embodiments, example configurations, andvariations thereof. In this regard, each block in the flowchart or blockdiagrams may represent a module, segment, step, or portion of code,which comprises one or more executable instructions for implementing thespecified logical function(s). It should also be noted that, in somealternative implementations, the functions noted in the block can occurout of the order noted in the FIGURES. For example, two blocks shown insuccession may, in fact, be executed substantially concurrently, or theblocks may sometimes be executed in the reverse order, depending uponthe functionality involved. It will also be noted that each block of theblock diagrams and/or flowchart illustration, and combinations of blocksin the block diagrams and/or flowchart illustration, can be implementedby special purpose hardware-based systems that perform the specifiedfunctions or acts, or combinations of special purpose hardware andcomputer instructions.

As a person skilled in the art will recognize from the previous detaileddescription and from the figures and claims, modifications and changescan be made to the preferred embodiments of the invention withoutdeparting from the scope of this invention defined in the followingclaims.

What is claimed is:
 1. A biomonitoring system, comprising: a wearablesensor patch system having an adhesive substrate at a user-facingsurface of the wearable sensor patch system, a filament, and anelectronics subsystem, wherein the adhesive substrate includes anadhesive configured to facilitate adhering the wearable sensor patchsystem to a user's skin such that the wearable patch system remainsadhered to the user for at least a plurality of days after the wearablesensor patch is initially adhered to the user's skin, and wherein thewearable sensor patch system is configured to detect a parameter of ananalyte in fluid of the user when the wearable sensor patch system isadhered to the user's skin and at least a portion of the filament isinserted into the user's tissue; and an applicator having a first modeand a second mode, the applicator including— a first applicator portionconfigured to releasably retain the wearable sensor patch system atleast when the applicator is in the first mode, a second applicatorportion configured to circumscribe the first applicator portion at leastwhen the applicator is in the first mode, a spring positioned betweenthe first applicator portion and the second applicator portion at leastwhen the applicator is in the first mode, wherein the spring has (a) afirst state of compression corresponding to when the applicator is inthe first mode and (b) a second, lower state of compressioncorresponding to when the applicator is in the second mode, and atrigger mechanism actuatable to initiate transitioning the applicatorfrom the first mode to the second mode, activable wherein, when theapplicator transitions from the first mode toward the second mode, (i)the spring transitions from the first state of compression toward thesecond state of compression, and (ii) the spring advances the wearablesensor patch system toward the user's skin such that the wearable sensorpatch system is adhered to the user's skin by the adhesive and such thatat least the portion of the filament is inserted into the user's tissue.2. The biomonitoring system of claim 1, wherein the first applicatorportion is positioned within the interior of the second applicatorportion such that the second applicator portion surrounds the firstapplicator portion so as to control motion of the first applicatorportion within the second applicator portion while (a) the applicatortransitions from the first mode toward the second mode and (b) thewearable sensor patch system is advanced toward the user's skin.
 3. Thebiomonitoring system of claim 1, wherein the wearable sensor patchsystem is at least partially positioned within the interior of thesecond applicator portion at least when the wearable sensor patch systemis releasably retained by the first applicator portion and theapplicator is in the first mode.
 4. The biomonitoring system of claim 1,wherein the applicator further includes a structure that at leastpartially obscures the wearable sensor patch system from the user's viewat least when the applicator is in the first mode.
 5. The biomonitoringsystem of claim 1, wherein the applicator further includes a retainerconfigured to: when the applicator is in the first mode, retain thespring in the first state of compression; and when the applicatortransitions from the first mode toward the second mode, allow the spring(i) to transition from the first state of compression toward the secondstate of compression and (ii) to advance the wearable sensor patchsystem toward the user's skin.
 6. The biomonitoring system of claim 5,wherein: the retainer is a mechanical latching mechanism; and thetrigger mechanism is configured, upon actuation, to cause unlatching ofthe retainer such that the applicator transitions from the first modetoward the second mode.
 7. The biomonitoring system of claim 1, wherein,when (a) the applicator transitions from the first mode toward thesecond mode and (b) the spring transitions from the first state ofcompression toward the second state of compression, the wearable sensorpatch system is advanced toward the skin of the user such that thewearable sensor patch system moves at a speed greater than 3 m/s beforeimpact with the user's skin.
 8. The biomonitoring system of claim 1,wherein the spring is spaced apart from sidewalls of the secondapplicator portion such that, when the applicator transitions from thefirst mode toward the second mode, the spring transitions from the firststate of compression toward the second state of compression withoutcontacting the sidewalls of the second applicator portion.
 9. Thebiomonitoring system of claim 1, further comprising a cap configured tosurround the filament such that the filament is not exposed at leastwhen the cap is installed.
 10. The biomonitoring system of claim 1,wherein: the spring is a first spring; the first spring transitions fromthe first state of compression toward the second state of compressionsubstantially along a first axis; the applicator further comprises asecond spring; the second spring is configured to transition between athird state of compression and a fourth state of compression lower thanthe third state of compression; and the second spring transitionsbetween the third state of compression and the fourth state ofcompression along a second axis substantially parallel to the firstaxis.
 11. The biomonitoring system of claim 1, wherein at least a partof the filament is exposed at a location offset from a center of theuser-facing surface.
 12. The biomonitoring system of claim 1, wherein atleast a part of the filament is exposed at a center location of theuser-facing surface.
 13. The biomonitoring system of claim 1, furthercomprising a needle configured to extend into the user's tissue.
 14. Thebiomonitoring system of claim 1, wherein the first applicator portionincludes a coupling interface configured to: when the applicator is inthe first mode, interface with at least a portion of the wearable sensorpatch system to releasably retain the wearable sensor patch system; andafter the wearable sensor patch system impacts the user's skin when theapplicator transitions from the first mode toward the second mode,release the wearable sensor patch system such that the first applicatorportion can be disconnected from the wearable sensor patch system. 15.The biomonitoring system of claim 1, wherein: the spring is configuredto transition from the first state of compression toward the secondstate of compression substantially along an axis; at least a portion ofthe trigger mechanism is exposed at an exterior of the second applicatorportion; and at least the portion of the trigger mechanism is positionedin line with the spring and substantially along the axis.
 16. Thebiomonitoring system of claim 1, wherein: the spring is configured totransition from the first state of compression toward the second stateof compression substantially along an axis; at least a first portion ofthe trigger mechanism is exposed at an exterior of the second applicatorportion; and at least a second portion of the trigger mechanism ispositioned out of line with the spring and offset from the axis.
 17. Thebiomonitoring system of claim 1, wherein the filament includes: acolumnar protrusion, the columnar protrusion having a proximal portionnear the user-facing surface and a distal portion at an end portion ofthe columnar protrusion opposite the proximal portion; a conical tipregion coupled to the distal portion of the columnar protrusion; aconductive portion; and an insulating layer positioned between theconductive portion of the filament and the proximal portion of thecolumnar protrusion.
 18. A method of manufacturing a biomonitoringsystem including (a) an applicator and (b) a wearable sensor patchsystem configured to be worn by a user for at least several days afteradherence to the user's skin, the wearable sensor patch system includinga filament used to detect a parameter of an analyte in fluid, and themethod comprising: releasably retaining the wearable sensor patch systemusing a first applicator portion of the applicator; transitioning aspring within an interior of a second applicator portion of theapplicator from a first state of compression to a second, higher stateof compression, wherein, at least while the first applicator portionreleasably retains the wearable sensor patch system and the spring is inthe second state of compression— the spring is positioned between thesecond applicator portion and the wearable sensor patch system, thesecond applicator portion at least partially circumscribes the firstapplicator portion, and the first applicator portion releasably retainsthe wearable sensor patch system such that at least a part of thefilament of the wearable sensor patch system is oriented in a directionparallel to a path passing through an opening of the second applicatorportion from the interior of the second applicator portion to anexterior of the second applicator portion; and reversibly retaining thespring in the second state of compression such that a trigger mechanismof the applicator is actuatable to cause a transition of the spring fromthe second state of compression toward the first state of compression toadvance the wearable sensor patch system in the direction parallel tothe path passing through the opening to, when the applicator is alignedwith the user's body and at least a portion of the filament ispositioned into the user's skin, adhere the wearable sensor patch systemto the user's skin using an exposed adhesive at a user-facing surface ofthe wearable sensor patch system.
 19. The method of claim 18, wherein:the first applicator portion includes a coupling interface; andreleasably retaining the wearable sensor patch system includes couplingthe first applicator portion to at least a portion of a housing of thewearable sensor patch system using the coupling interface.
 20. Themethod of claim 18, wherein, at least while the first applicator portionreleasably retains the wearable sensor patch system and the spring is inthe second state of compression, (a) at least a portion of the wearablesensor patch system is positioned within the interior of the secondapplicator portion and/or (b) the wearable sensor patch system is atleast partially obscured from a user's view by a structure of theapplicator.
 21. The method of claim 18, further comprising reversiblyretaining the first applicator portion within the interior of the secondapplicator portion, wherein reversibly retaining the first applicatorportion within the interior of the second applicator portion include slimiting movement of the first applicator portion in the directionparallel to the path passing through the opening from the interior ofthe second applicator portion to the exterior of the second applicatorportion.
 22. The method of claim 21, wherein: reversibly retaining thefirst applicator portion within the interior of the second applicatorportions includes reversibly retaining the first applicator portionusing a retainer; the retainer is a protrusion; and reversibly retainingthe first applicator portion within the interior of the secondapplicator portion further includes moving the retainer toward acorresponding recessed region of the applicator.
 23. A method ofapplying a biomonitoring system including (a) an applicator and (b) awearable sensor patch system configured to be worn by a user for atleast several days after adherence to the user's skin, the wearablesensor patch system having a filament used to detect a parameter of ananalyte in fluid, and the method comprising: transitioning, based atleast in part on actuation of a trigger mechanism of the applicator andwhile the applicator is aligned with a user's body, the applicator froma first mode toward a second mode, wherein the applicator in the firstmode includes (i) a second applicator portion having an opening, (ii) afirst applicator portion releasably retaining the wearable sensor patchsystem, and (iii) a spring positioned within the interior of the secondapplicator portion and held in a first state of compression, andwherein, while the applicator is aligned with a user's body and theapplicator is in the first mode, at least a part of the filament isdirected toward the user's skin, wherein the wearable sensor patchincludes an adhesive, and wherein transitioning the applicator from thefirst mode toward the second mode includes transitioning the spring fromthe first state of compression toward a second, lower state ofcompression such that (i) the spring moves the wearable sensor patchsystem toward the user's skin, (ii) the wearable sensor patch is adheredto the user's skin using the adhesive, and (iii) at least a portion ofthe filament is inserted into the user's tissue such that the filamentcontacts fluid in the user.
 24. The method of claim 23, furthercomprising reversibly retaining the first applicator portion within thesecond applicator portion using a retainer, wherein transitioning theapplicator from the first mode toward the second mode based at least inpart on actuation of the trigger mechanism includes disengaging theretainer.
 25. The method of claim 23, wherein transitioning theapplicator from the first mode toward the second mode further includescontrolling, using the second applicator portion, lateral motion of thewearable sensor patch system as the wearable sensor patch system ismoved toward the user's skin.
 26. The method of claim 23, wherein: thebiomonitoring system further comprises a needle insertable into theuser's tissue; and wherein transitioning the applicator from the firstmode toward the second mode includes moving the needle and the filamentalong parallel paths towards the user's skin as the wearable sensorpatch system is moved toward the user's skin.
 27. The method of claim23, wherein transitioning the spring from the first state of compressiontoward the second state of compression includes transitioning the springfrom the first state of compression toward the second state ofcompression such that the wearable sensor patch system moves at a speedgreater than 3 m/s before impact with the user's skin.
 28. The method ofclaim 23, wherein the wearable sensor patch system further includes ahousing, wherein the filament is at least partially positioned exteriorthe housing, and wherein transitioning the spring from the first stateof compression toward the second state of compression includestransitioning the spring from the first state of compression toward thesecond state of compression such that an entire length of the exposedportion of the filament is extended into the user's tissue.
 29. Themethod of claim 23, further comprising releasing the wearable sensorpatch system such that the wearable sensor patch system is disconnectedfrom the first applicator portion.